consensus on recording deep endometriosis surgery (cordes) … · †presented at eshre precongress...

REVIEW Gynaecology

Consensus on Recording DeepEndometriosis Surgery (CORDES)Part I: standardized reporting ofsurgical procedures†

A. Vanhie1, C. Meuleman1, C. Tomassetti1, D. Timmerman1,A. D’Hoore2, A. Wolthuis2, B. Van Cleynenbreugel3, E. Dancet2,U. Van den Broeck1, J. Tsaltas4, S.P. Renner5, A.D. Ebert6, F. Carmona7,J. Abbott8, A. Stepniewska9, H. Taylor10, E. Saridogan11, M. Mueller12,J. Keckstein13, N. Pluchino14, G. Janik15,16, E. Zupi17, L. Minelli9,M. Cooper18, G. Dunselman19,20, C. Koh21, M. Abrao22,23,C. Chapron24,25, and T. D’Hooghe1,26,27,*1Department of Obstetrics and Gynecology, University Hospital Leuven, Leuven, Belgium 2Department of Abdominal Surgery, UniversityHospital Leuven, Leuven, Belgium 3Department of Urology, University Hospital Leuven, Leuven, Belgium 4Monash Health and Monash University,Melbourne, VIC, Australia 5Frauenklinik, Universitaetsklinikum Erlangen, Erlangen, Germany 6Praxis fur Frauengesundheit, Gynakologie undGeburtshilfe, Berlin, Germany 7Service of Gynecology, Hospital Clinic of Barcelona, University of Barcelona, Barcelona, Spain 8Royal Hospital forWomen and University of New South Wales, Sydney, Australia 9Department of Obstetrics and Gynecology, Ospedale Sacro Cuore, Verona, Italy10Yale School of Medicine, New Haven, CT, USA 11University College London Hospitals, London, UK 12Universitatsklinik fur Frauenheilkunde,Universitatsspital Bern, Bern, Switzerland 13Landeskrankenanstalten-Betriebsgesellschaft (KABEG) and Landeskrankenhaus Villach, Abteilung furGynakologie und Geburtshilfe, Villach, Austria 14Department of Obstetrics and Gynecology, University Hospital of Geneva, Geneva, Switzerland15Reproductive Specialty Center, Columbia St. Mary’s Hospital, Milwaukee, WI, USA 16Medical College of Wisconsin, Milwaukee, WI, USA17University of Siena, Siena, Italy 18Department of Obstetrics and Gynaecology, Sydney University, Sydney, Australia 19Department of Obstetrics& Gynaecology, Research Institute GROW, Maastricht, The Netherlands 20University Medical Centre, PO Box 5800, 6202 AZ Maastricht, TheNetherlands 21Milwaukee Institute of Minimally invasive Surgery, Milwaukee, WI, USA 22Division of Reproductive Medicine, Sirio LibanesHospital, Sao Paulo, Brazil 23Division of Endometriosis, Department of Obstetrics and Gynaecology, Sao Paulo University, Sao Paulo, Brazil24Faculty of Medicine, Universite Paris Descartes, Sorbonne Paris Cite, Paris, France 25Department of Gynecology, Obstetrics, and ReproductiveMedicine, Centre Hospitalier Universitaire Cochin of the Groupe Hospitalier Universitaire Ouest, Paris, France 26Faculty of Medicine, LeuvenUniversity, Leuven, Belgium 27Faculty of Medicine, Yale University, New Haven, CT, USA

*Correspondence address. Department of Obstetrics and Gynecology, University Hospital Gasthuisberg, and Department ofDevelopment and Regeneration, Group Biomedical Sciences, KU Leuven (University of Leuven), Herestraat 49, 3000 Leuven, Belgium.E-mail: [email protected]

Submitted on November 12, 2014; resubmitted on December 15, 2015; accepted on January 5, 2016

study question: What are all the essential items that should be recorded when performing surgery for deep endometriosis (DE)?

summaryanswer: We have developed the deep endometriosis surgical sheet (DESS) for standardized reporting of the essential items insurgical treatment of DE.

what is known already: Surgery is an important treatment for symptomatic DE. So far, data have been reported in such a way thatcomparison of different surgical techniques is impossible. Therefore, we present an international expert proposal for standardized reporting ofsurgical treatment in women with DE.

study design, size, duration: A proposal was developed by international experts based on a systematic review of literature.

participants/materials, setting, methods: Taking into account recommendations from the Innovation Development

†Presented at ESHRE Precongress Course on Endometriosis and Pain, 1 July 2012 during the 28th Annual ESHRE Meeting, Istanbul, Turkey, 1–4th July; at the 2nd Congress of the EuropeanEndometriosis League (EEL), (Session 3 ‘Pain and Cancer’), Berlin, Germany, 28–30 November, 2013 and at the Deep Infiltrating Endometriosis symposium, organized by the Endometriosisand Adenomyosis Society of Turkey together with the Turkish Society of Gynecological Endoscopy, Istanbul, 18–19 January , 2014.

& The Author 2016. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved.For Permissions, please email: [email protected]

Human Reproduction, Vol.0, No.0 pp. 1–23, 2016

doi:10.1093/humrep/dew067

Exploration Assessment and Long-term Study (IDEAL) and World Endometriosis Research Foundation Phenome and Biobanking HarmonisationProject (WERF EPHect), a systematic literature review on surgical treatment of DE was performed and resulted in a proposal for standardizedreporting, adapted by contributions from eight members of the multidisciplinary Leuven University Hospitals Endometriosis Care Program, from18 international experts and from audience feedback during three international meetings.

main results and the role of chance: We have developed the DESS, which is an instrument to record in detail the extent ofendometriosis, surgical procedures and all essential pre-and post-operative information when performing surgery for DE. All items in the DESSwere defined and are described in detail to maximize the standardization of the recording and reporting of surgery for DE.

limitations, reasons for caution: For several items and recommendations there are no high-quality RCTs available. Furtherresearch is needed to validate and evaluate the recommendations presented here.

wider implications of the findings: This international expert consensus for standardized reporting of surgical treatment inwomen with DE can be used as a guideline to record and report surgical management of patients with DE.

study funding/competing interest(s): None of the authors received funding for the development of this paper. M.A. reportspersonal fees and non-financial support from Bayer Pharma outside the submitted work; H.T. reports a grant from Pfizer and personal fees forbeing on the advisory board of Perrigo, Abbvie, Allergan and SPD.

trial registration number: N/A.

Key words: endometriosis / deep endometriosis / surgery / standardization of reporting / terms and definitions / consensus

IntroductionDeep endometriosis (DE), defined as infiltrating deeper than 5 mmunder the peritoneum, is a multifocal pathology that may infiltrate differ-ent pelvic locations: intestine, vagina, uterosacral ligaments, bladder andureter (Chapron et al., 2010; Dunselman et al., 2014). In women with DE,intestinal and urinary tract involvement are estimated to occur in 3.8–37% and 1–2% of women, respectively (Meuleman et al., 2011; Kumaret al., 2012). Surgical treatment is considered to be the treatment ofchoice for symptomatic DE with colorectal and urological extension(Chapron et al., 2004; Ret Davalos et al., 2007). Nevertheless it is pos-sible that asymptomatic DE can give rise to ureteral obstruction with asilent loss of kidney function (Soriano et al., 2011). Surgery for DEappears possible and effective, but is associated with significant compli-cation rates (Dunselman et al., 2014). The European Society of HumanReproduction and Embryology (ESHRE) guideline on the managementof women with endometriosis recommends that treatment of DEshould be performed by multidisciplinary teams in centers with specificexpertise in this area (Dunselman et al., 2014). Several techniques forthe excision of DE lesions have been described and evaluated, butlarge, well designed, prospective RCTs are lacking. Systematic reviewson the surgical treatment of DE demonstrate that it is impossible to inter-pret the literature due to unclear definitions, lack of standardization andincompleteness in reporting interventions, clinical inclusion and outcomedata (De Cicco et al., 2011; Meuleman et al., 2011).

The incomplete and unstandardized reporting is not specific for surgi-cal trials on DE but is a major problem in endometriosis research ingeneral. Therefore, the World Endometriosis Research FoundationPhenome and Biobanking Harmonisation Project (WERF-EPHect) waslaunched. This is a global initiative, involving 34 clinical/academic andthree industrial collaborators from 16 countries with the mission todevelop a consensus on standardization and harmonization of phenotyp-ic surgical/clinical data and biological sample collection methods in endo-metriosis research (Becker et al., 2014; Casper , 2014; Fassbender et al.,2014; Rahmioglu et al., 2014; Vitonis et al., 2014). The WERF EPHectproject provides guidelines on the detailed surgical, clinical and

epidemiological phenotyping data to be collected from women withand without endometriosis toallow collaborative subphenotype discoveryand validation analyses and standard operating procedures for collection,processing and long-term storage of biological samples from womenwith and without endometriosis (Becker et al., 2014; Casper , 2014;Fassbender et al., 2014; Rahmioglu et al., 2014; Vitonis et al., 2014). TheWERF-EPHect includes a standard surgical form (EPHect-SSF) for therecording of surgical phenotypic information in endometriosis research(Becker et al., 2014). Widespread implementation of the WERF-SSF willhopefully lead to more standardization in the recording and reporting ofsurgical procedures for endometriosis.

We believe that a similar initiative like the WERF-EPHect is needed forthe standardization and harmonization of data collection in surgical trialson DE. The first and most important step towards large-scale, inter-national, controlled surgical trials on DE is standardizing the reportingof the DE surgery. This requires detailed registration of all importantaspects of these complex surgical procedures, from the pre-operativeplanning to the post-operative period. Therefore, we present a Consen-sus On Recording Deep Endometriosis Surgery (CORDES). TheCORDES statement comprises two papers (Part I and Part II), whichare available online in Human Reproduction. Part I covers the standardizedreporting of surgical procedures. Part II (Vanhie et al., 2016, Part II)focuses on the standardized reporting of surgical trials. An ExecutiveSummary (Vanhie et al., 2016) summarizes both full-length articles.

MethodsThe ‘Consensus On Recording Deep Endometriosis Surgery: standardizedreporting of surgical procedures’ has been developed based on theWERF-EPHect surgical form (Becker et al., 2014), an existing checklist (Meu-leman et al., 2011, 2012), an extensive literature search, multiple consensusmeetings with experts of the Leuven endometriosis team and input frominternational experts in the surgical treatment of DE (S.P.R., J.T., A.D.E.,F.C., J.A., A.S., H.T., E.S., M.M., J.K., N.P., M.C., G.D., C.K., C.C., M.A.).

As a starting point, we used the WERF-EPHect surgical form published byBecker et al. (2014) on behalf of the WERF EPHect Working group and an

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http://humrep.oxfordjournals.org/lookup/suppl/doi:10.1093/humrep/dew067/-/DC2

http://humrep.oxfordjournals.org/lookup/suppl/doi:10.1093/humrep/dew067/-/DC2

existing checklist, which is CONSORT-based, and has been published as asupplementary table in a systematic review paper on surgical treatment ofDE and as a full table in another review paper on the same subject (Meulemanet al., 2011, 2012).

During the first stage, a systematic literature search was performed usingthe PubMed/Medline database between October 2011 and 31 December2013. Using the search terms ‘deeply infiltrating endometriosis’ and ‘deependometriosis’ in combination with ‘treatment’, a total of 84 and 382titles, respectively, were retrieved. Out of these titles, 318 papers were con-sidered to be relevant and their abstracts were read in order to identify sys-tematic reviews, meta-analyses and reviews concerning the surgicaltreatment of deeply infiltrating endometriosis. A total of 22 reviews, system-atic reviews and meta-analyses were identified and analyzed in detail for dataabout reporting of endometriosis surgery. This systematic literature searchwas updated in January 2015 using the same search terms. This resulted inthe inclusion of four additional (systematic) reviews.

When these 26 (22 + 4) papers from the systematic literature reviewwere checked for other publications on specific definitions or items aboutreporting of endometriosis surgery, these publications were then alsoincluded for detailed analysis (¼ cross-referencing). Through cross-referencing, 25 additional relevant publications were identified and included.These 51 papers were analyzed with respect to areas relevant to the surgicalinterventions performed for DE (Supplementary Table SI). Based on theresults of this literature search, an extensive list was made of items relevantin the reporting of surgical procedures for DE.

During the second stage we compared the WERF-EPHect surgical form(Becker et al., 2014) and the existing checklist (Meuleman et al., 2011,2012) with the extensive list resulting from the literature study. This resultedin a first draft version of the ‘deep endometriosis surgical sheet’ (DESS). Thisfirst draft version was reviewed separately by two gynecologists (coauthorsC.M. and C.T.) with .20 (C.M.) and 5 (C.T.) years of expertise in the surgicaltreatment of DE, and who have collectively performed 5800 surgeries inwomen with endometriosis before 31 December 2014. These expertsmade suggestions for expansion of items or suggested new items thatneeded inclusion.

During the third stage, all items and procedures from the DESS were pre-cisely defined, based on the definitions used in the papers from the literaturesearch and from several reference papers recommended by experts from themultidisciplinary Leuven Endometriosis Surgical Team.

In a fourth stage, consensus was reached on the DE surgical sheet amongsenior staff members of the multidisciplinary Leuven Endometriosis SurgicalTeam, whose members have been working together since 1996. Additionalexperts included a gynecologist with expertise in endometriosis research,medical and infertility treatment, and guideline development (T.D.), a urolo-gist (B.V.C.) and abdominal surgeons (A.D. and A.W.) with expertise in lap-aroscopic surgical treatment of urological and bowel endometriosis,respectively. Experts suggested necessary changes to the draft version ofthe DE surgical sheet and added new items.

During the final stage, international experts in DE surgery and in endomet-riosis research were contacted, invited to be coauthors, and were asked tooffer feedback. In order to obtain an instrument that is based on broad con-sensus regarding its feasibility and completeness, we included a large numberof international experts. All authors reviewed the manuscript and were ableto add items and remarks. International experts added extra items to beincluded in the DESS, changed the definitions of several surgical proceduresand gave important input on the description of the pre- and post-operativemanagement. This resulted in the final version of the DE surgical sheet,which was then presented for approval to all coauthors. The internationalexperts who agreed to be coauthors reviewed draft versions of this paper,added significant content and approved the final version of the consensusstatement presented here (Supplementary Information).

ResultsWe have developed the DESS (see Supplementary Information). TheDESS consist of four major parts: essential pre-operative information,a detailed description and staging of the endometriosis at the start ofthe surgery, a detailed description of the surgical procedures and essen-tial post-operative information. In Table I an overview is presented fromthe recommendations for standardized recording and reporting of thesurgical treatment of DE.

Essential pre-operative informationEssential clinical covariatesA large number of patients undergoing surgery for DE will be under someform of medical treatment (Furness et al., 2004). Although a Cochranereview showed no evidence of a benefit of pre-operative medical therapyon the outcome of surgery, the ESHRE guideline on management of endo-metriosis endorses that pre-operative treatment with GnRH-analoguesto facilitate surgery is common clinical practice (Furness et al., 2004;

Table I Standardized reporting of surgical treatmentfor deep endometriosis (DE).

Record essential pre-operative information

† Essential clinical covariates

8 Menstrual history and current hormonal treatment

8 Previous endometriosis surgery

8 Pre-operative imaging results

8 Use of prophylactic drugs† Indications and decision on type of surgery

Record detailed description and staging of endometriosis

† Staging: ASRM and EFI (optional: ENZIAN)† Extent of peritoneal/superficial endometriosis

8 Number, size and exact localization of each lesion† Extent of ovarian endometriosis

8 Number, size and localization of endometrioma(s)† Extent of deep endometriosis

8 Number, size and exact localization of each lesion

8 Bowel DE:

B Depth of infiltration in intestinal wallB Circumferential involvementB Distance to anal verge

8 Urological DE:

B Depth of infiltration in bladder and ureterB Presence of hydro-ureteronephrosis

† Extent of adhesions

Record detailed description of surgical procedures performed

† Clear description of surgical procedures performed (standardizedterminology)

† Record surgical risk factors for negative outcomes

Record essential post-operative information

† Operation times, length of hospital stay and post-operative management† Detailed description of the abdomen after surgery† Detailed histological report† Intra and post-operative complications

ASRM, American Society for Reproductive Medicine; EFI, endometriosis fertilityindex.

Consensus on Reporting Deep Endometriosis Surgery CORDES 3

Dunselman et al., 2014). The use of any hormonal treatment and the men-strual cycle at the moment of surgery will influence the visual aspect of theendometriosis lesions, therefore this is considered as essential information(Becker et al., 2014). Previous endometriosis surgery and the results of anypre-operative imagingaremajordeterminants for theextentandcomplexityof the surgery (Chapron et al., 2004; Abrao et al., 2015). Therefore we rec-ommend documenting a summary of the pre-operative imaging results andprevious endometriosis surgery.

Indications and decision on type of surgeryThere is no general consensus about the exact indications for surgery inpatients with DE and an ongoing debateabout which technique should beused in which situation (Dunselman et al., 2014). Two systematic reviewsabout the surgical treatment of bowel endometriosis have shown thatthere is a lot of variability among studies regarding the indication forsurgery (De Cicco et al., 2011; Meuleman et al., 2011). Furthermore,the decision for the use of a specific technique, e.g. discoid excisionversus bowel resection, is often not documented in detail or not reportedat all (De Cicco et al., 2011). Treatment algorithms for DE with bowel orurological involvement have been published, but large prospective RCTscomparing different surgical techniques and different treatment strategiesare lacking (Chapronetal., 2004; Gustilo-Ashbyand Paraiso, 2006; Vercel-lini et al., 2009; Soriano et al., 2011; Maccagnano et al., 2013; Abrao et al.,2015). To allow clinical evaluation and further optimization of these treat-ment algorithms, systematic reporting of the indication and the decisionprocess for the surgical technique is essential.

Detailed description and staging ofendometriosisEndometriosis is a complex disease and there is no ‘perfect’ stagingsystem available at present. By far the most commonly used and best-known staging system is the revised American Society for ReproductiveMedicine classification (rASRM) (ASRM, 1996). Major limitations of therASRM classification are the limited reproducibility and poor correlationwith pelvic pain and infertility (Adamson, 2011). The endometriosis fer-tility index (EFI) has been shown to predict non-IVF pregnancy rates forpatients following surgical staging and treatment of endometriosis, andhas been externally validated (Adamson and Past, 2010; Tomassettiet al., 2013). However, both rASRM and EFI staging systems fail to classifyDE. In order to supplement the rASRM classification with regard tothe description of DE, the ENZIAN score was introduced in 2003 andrevised in 2011 (Keckstein et al., 2003; Tuttlies et al., 2005; Haas et al.,2013a,b). Although the ENZIAN score appears to be an excellent com-plement to the rASRM score for morphological description of DE, it hasrarely been used outside German speaking European countries (Tuttlieset al., 2005; Haas et al., 2013a,b). The WERF-EPHect surgical formincludes staging using both the ASRM and EFI system, to which wehave added optional staging with the ENZIAN score given its value inthe planning of the surgery (Tuttlies et al., 2005; Becker et al., 2014;Abrao et al., 2015).

In many patients having surgery for DE there are also superficial endo-metriotic lesions and endometriomas (Chapron et al., 2004; Vercelliniet al., 2009; Meuleman et al., 2011; Koninckx et al., 2012). Therefore adetailed description of the extent of all superficial, ovarian and DE isrequired, ideally supported by representative pictures and/or videofragments (Becker et al., 2014). This includes the number, size andexact location of each lesion (superficial or deep), the presence of

endometriomas, hydrosalpinges and the extent of adhesions (Beckeret al., 2014). For bowel endometriosis the localization and number of dif-ferent intestinal DE lesions (multifocality), the depth of intestinal DElesion(s) in the intestinal wall (with specification of deepest layer affectedby endometriosis), the circumferential involvement and the distancebetween intestinal DE lesion(s) and anal verge should be documented(Chapron et al., 2004; Abrao et al., 2015). The description of theextent of urological endometriosis should include the localization andnumber of different urinary tract DE lesions (multifocality), depth ofurinary tract DE lesions (depth of infiltration in the bladder wall, intrin-sic/extrinsic ureteral endometriosis) and the presence of hydro-ureteronephrosis (Soriano et al., 2011; Maccagnano et al., 2013).

Description of surgical procedureClear description of all surgical procedures performedA major strength of the WERF-EPHect surgical form is the registration ofall individual procedures that were performed during the operation(Becker et al., 2014). Given the complexity of surgery for DE, with riskfor significant complications, a thorough recording of every surgical inter-vention and intra-operative complication is indispensable. To maximizethe standardization of the terminology used to describe the differentsteps in the operation, wehaveprecisely defined the mostcommon tech-niques in the treatment of DE (see Tables II and III).

When novel and innovative techniques are being used or studied, suchas the combined laparoscopic and transanal approach for nodules of thelow and middle rectum (Rouen technique), they should be described indetail (Bridoux et al., 2012; Roman and Tuech, 2014).

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Table II Definitions of procedures for bowelendometriosis.

Procedure Definition

Bowel shaving Superficial excision of bowel serosal andsubserosal endometriosis (mechanically, withdiathermy, laser or other energy source) thatdoes not require suturing/closure.

Bowel partial thicknessdiscoid excision

Selective excision of the bowel endometriosislesion (mechanically, with diathermy, laser orother energy source) without entering thebowel lumen, that requires suturing/closure.(i.e. closure of a muscularis defect without amucosal defect in the bowel wall)

Bowel full thicknessdiscoid excision

Selective excision of the bowel endometriosislesion (mechanically, with diathermy, laser orother energy source) with opening of thebowel lumen followed by closure of thebowel.Subtypes:(1) Open full thickness disc excision: excision

with opening of lumen followed byclosure

(2) Closed full thickness disc excision:excision with stapler

Bowel resection andre-anastomosis

Resection of a bowel segment affected byendometriosis followed by re-anastomosis byany means.

4 Vanhie et al.

Surgical risk factors for complicationsConsidering the major complications associated with surgery for DE,there are several frequently observed risk factors: opening and suturingof the vagina, excessive use of electrocoagulation, surgical treatment oflow rectal lesions (5–8 cm from the anal verge), opening and suturingof the bladder, opening and suturing of the ureter and re-anastomosisor re-implantation of the ureter(s) (Dubernard et al., 2006; Minelliet al., 2009; Ruffo et al., 2010; Kondo et al., 2011; Meuleman et al.,2011; Soriano et al., 2011; Maccagnano et al., 2013; Abrao et al.,2015). Therefore we recommend to record these risk factors in detail.

Essential post-operative informationOperation times, length of hospital stay and post-operativemanagementDepending on hospital policy and the multidisciplinary team, there mightbe significant differences between endometriosis centers in the use ofprophylactic drugs (i.e. all drugs used to facilitate surgery or preventthe development of complications), the use of time in the operationtheatre, the post-operative management, the discharge policy and theuse of post-surgery hormonal medication for secondary prevention(McCulloch et al., 2009). These variables can be a very importantsource of bias in evaluating surgical techniques and thus should berecorded and explained in detail (McCulloch et al., 2009). We havedefined four different operation times (door-to-door time, narcosis

time, skin-to-skin time and net operation time, see Table IV). Authorsare recommended to report systematically skin to skin time and net op-eration time.

Description of the abdomen after surgeryThe main objective of surgical treatment of DE is the complete excision ofall endometriotic lesions. The presence of any residual disease is very im-portant, since the completeness of surgical excision has been correlatedwith higher recurrence rates (Nirgianakis et al., 2014; Sibiude et al.,2014). Complementary with the detailed description of the extent ofendometriosis and the surgical procedures performed, there shouldbe a detailed description of the pelvis/abdomen at the end of thesurgery (Becker et al., 2014). This should include a detailed written sur-gical report, again ideally supported by representative pictures and/orvideo fragments, with specific attention to all localizations specified inthe description of the extent of endometriosis at the start of thesurgery (Becker et al., 2014). The presence and extent of residual endo-metriosis should be documented meticulously, with description of thenumber, localization and size of the residual lesions.

Detailed histology reportHistologic confirmation of all resected lesions should be obtained andshould include the histologic type/pattern, the largest diameter ofeach lesion, the depth of invasion in the bowel, bladder or ureter, thelength of the resected bowel segment(s), the presence of lymphatic dis-semination and the presence of positive section margins (Remorgidaet al., 2005; Meuleman et al., 2011, 2012; Abrao et al., 2015). Since posi-tive section margins after bowel resection is a risk factor for recurrence,the number and location of the positive margin(s) should be recorded(Nirgianakis et al., 2014).

Intra and post-operative complicationsAs stated earlier, there is an ongoing debate about the risk ofcomplications associated with different surgical techniques used in DE(Dunselman et al., 2014). To allow comparison of techniques, the stan-dardized reporting of all complications is a prerequisite (McCulloch et al.,2009). The Clavien-Dindo Classification of surgical complications iswidely used in the surgical literature and is recommended in theIDEAL-statement (Innovation Development Exploration Assessmentand Long-term study) for improving surgical innovation and evaluation(Dindo et al., 2004; Clavien et al., 2009; McCulloch et al., 2009). Morerecently a comprehensive complication index was introduced to sum-marize all post-operative complications (Slankamenac et al., 2013). In

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Table III Definitions of procedures for urinary tractendometriosis.

Procedure Definition

Ureterolysis Restoration of the normal mobility and anatomicalposition of the ureter through resection ofadhesions and selective dissection of the ureterfrom a lesion, either mechanically or withdiathermy, laser or any other energy source.Subtypes:(1) Without opening of the ureteric wall(2) With opening and re-suturing of the

ureteric wall.

Ureteral segmentalresection

Resection of a ureteral segment affected byendometriosis followed by ipsilateraluretero-ureteral re-anastomosis or ureteralreimplantation into the bladder.

Bladder shaving Superficial excision of bladder serosal andsubserosal endometriosis (mechanically, withdiathermy, laserorotherenergysource) thatdoesnot require suturing/closure.

Bladder partialthickness excision

Selective excision of the bladder endometriosislesion (mechanically, with diathermy, laser orother energy source) without opening of thebladder mucosa that requires suturing/closure.(i.e. closure of a muscularis defect without amucosal defect)

Bladder full thicknessexcision

Resection of an endometriosis nodule by fullthickness partial resection of the bladder wall,including the mucosa and closure of the defect bysuture or other device.

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Table IV Definitions of operation times.

Name Definition

Door to doortime

The time interval between entrance and exit of thepatient in the operation theatre (including pre-inductionservice, operation room and recovery area).

Narcosis time The time interval between induction and end of narcosis.

Skin to skin time The time interval between the first incision and the lastsuture.

Net operationtime

The sum of the time intervals each surgeon operated.


Table V the definitions of negative outcomes in surgery, as defined byClavien-Dindo, are shown (Dindo et al., 2004).

ConclusionThere is an ongoing debate about the indications for shaving, discoid ex-cision and segmental bowel resection for DE lesions. What we provide inthis paper is a standardized protocol for the recording and reporting ofthe surgical procedures used in the treatment of DE, regardless of thetechnique used. The ‘Consensus On Recording Deep EndometriosisSurgery part 1: standardized reporting of surgical procedures’ has beendeveloped based on the WERF-EPHect surgical form (Becker et al.,2014), an existing checklist (Meuleman et al., 2011, 2012), an extensiveliterature search, multiple consensus meetings with experts of theLeuven endometriosis team and input from international experts in thesurgical treatment of DE.

We have developed the DESS, included as Supplementary Informa-tion to this paper. The DESS consist of four major parts: essential pre-operative information, a detailed description and staging of the endomet-riosis at the start of the surgery, a detailed description of the surgical pro-cedures and essential post-operative information.

We realize that the DESS is an exhaustive surgical sheet and that itincludes more items than are routinely recorded in current researchdatabases. Moreover it is important to realize that for several items inthe surgical sheet, no high-level evidence (i.e. RCTs) was available.Therefore the DESS should be considered as a first basis for

standardization of surgical reporting and future research might indicatethat adaptations are necessary. One of the major strengths of our surgicalsheet is that we have specifically chosen to adapt the WERF EPHect sur-gical form without excluding any items. This means that when the DESS isrecorded, all information necessary for the WERF EPHect is recordedsimultaneously. This ensures that the recorded information cannotonly be used for surgical research purposes but is also according to theEPHect standard for biobank samples and endometriosis research ingeneral, which compensates for the extra time invested in the recordingof the DESS. A second very important strength of the DESS is that it iseasy to implement because of the ‘ready to use’ format. This meansthat centers that do not routinely record and report their surgical datacan relatively easily start doing this by using the DESS. Furthermore, itwill be possible to use surgical data recorded in the DESS/WERFEPHect forms in raw data-based meta-analyses.

The aim of this paper is to harmonize and standardize the recordingand reporting of surgery in patients with DE. This is a first and essentialstep to enable large multicentric trials on the surgical management ofDE. This paper is one part of two international expert consensus state-ments to improve the standardization of reporting in surgical trials inwomen with DE.

Authors’ rolesThe paper was primarily designed and written by first author A.V. and bylast author T.D. All other coauthors contributed significantly to thecontent of this paper, added new concepts, provided additional relevantpapers, critically reviewed and improved draft versions of this paper.

FundingThis study was performed without specific funding.

Conflict of interestM.A. reports personal fees and non-financial support from Bayer Pharmaoutside the submitted work; H.T. reports a grant from Pfizer and person-al fees for being on the advisory board of Perrigo, Abbvie, Allergan andSPD.

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Table V Definitions of negative outcomes in surgery.

Term Definition

Complication Any deviation from the normal intra- and post-operativecourse. Includes also asymptomatic complications

Sequelae An ‘after-effect’ of surgery that is inherent to theprocedure, e.g. inability to walk after an amputation of theleg

Failure to cure Situation which occurs if the original purpose of surgeryhas not been achieved, e.g. residual endometriosis aftersurgery.

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Supplementary Table SI Results from systematic literature search.

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Long-term outcome after laparoscopic bowel resections for deep infiltrating endometriosis: asingle-center experience after 900 cases

CR

Dunselman et al.Hum Reprod. 2014 Mar;29(3):400–12

ESHRE guideline: management of women with endometriosis ES

Uccella et al. 2014Fertil Steril. 2014 Jul;102(1):160–166.e2

Laparoscopy for ureteral endometriosis: surgical details, long-term follow-up, and fertilityoutcomes

CR

Bourdel et al.Hum Reprod Update 2014; 21(1): 136–152

Systematic review of endometriosis pain assessment: how to choose a scale? CR

Fritzer et al.Eur J Obstet Gynecol Reprod Biol. 2013doi:10.1016/j.ejogrb.2013.10.032

Dyspareunia and quality of sex life after surgical excision of endometriosis: a systematic review ES

Roman H et al.Fertil Steril. 2013; 99(6):1695–704

Post-operative digestive function after radical versus conservative surgical philosophy for deependometriosis infiltrating the rectum.

CR

Maccagnano C et al.Urol Int. 2013;91(1):1–9

Ureteral endometriosis: proposal for a diagnostic and therapeutic algorithm with a review of theliterature

OS

Serati M et al.Fertil Steril. 2013 Nov;100(5):1332–6

Deep endometriosis and bladder and detrusor functions in women without urinary symptoms: apilot study through an unexplored world

CR

Bonneau C et al. 2013Minerva Ginecol. 2013 Aug;65(4):385–405

Incidence of pre- and post-operative urinary dysfunction associated with deep infiltratingendometriosis: relevance of urodynamic tests and therapeutic implications

CR

Roman H et al.Am J Obstet Gynecol. 2013b Dec;209(6):524–30

Bowel dysfunction before and after surgery for endometriosis CR

Koninckx et al.Fertil Steril 2012;98:564–571

Deep endometriosis: definition, diagnosis, and treatment OS

Meuleman et al.Curr Opin Obstet Gynecol 2012; 24(4): 245–252

Clinical outcome after laparoscopic radical excision of endometriosis and laparoscopic segmentalbowel resection

CR

Ruffo G et al. 2012Surg Endosc. 2012 Apr;26(4):1035–40

Laparoscopic rectal resection for severe endometriosis of the mid and low rectum: technique andoperative results

CR

Meuleman C et al. 2011Hum Reprod Update 2011; 17(3):311–26

Surgical treatment of deeply infiltrating endometriosis with colorectal involvement. OS

Nassif J et al. 2011Reprod Biomed Online 2011 Jul;23(1):25–33

Management of Deep endometriosis OS

Soriano D et al. 2011J Minim Inv Gynecol 2011; 18: 483–488

Multidisciplinary team approach to management of severe endometriosis affecting the ureter:long-term outcome data and treatment algorithm

OS

De Cicco C et al. 2011BJOG 2011; 118: 285–291

Bowel resection for deep endometriosis: a systematic review OS

Kondo W et al. 2011BJOG 2011; 118: 292–298

Complications after surgery for deeply infiltrating pelvic endometriosis CR

Pereira RM et al. 2010Curr Opin Obstet Gynecol 2010 Aug;22(4):344–53

The feasibility of laparoscopic bowel resection performed by a gynecologist to treat endometriosis OS

Maytham GD et al. 2010Colorectal Dis 2010 Nov;12(11):1105–12

Laparoscopic excision of rectovaginal endometriosis: report of a prospective study and review ofthe literature

OS

Camanni M et al. 2010Curr Opin Obstet Gynecol 2010;22(4):309–14

Laparoscopic conservative management of ureteral endometriosis CR

Continued


.............................................................................................................................................................................................

Supplementary Table SI Continued

Reference Title

Chapron C et al. 2010Fertil Steril 2010; 93: 2115–2120

Severe ureteral endometriosis: the intrinsic type is not so rare after complete surgical exeresis ofdeep endometriotic lesions

CR

Ruffo et al. 2010Surg Endosc 2010;24:63–67

Laparoscopic colorectal resection for deep infiltrating endometriosis: analysis of 436 cases CR

Dousset B et al. 2010Ann Surg 2010; 251: 887–95.

Complete surgery for low rectal endometriosis: long-term results of a 100-case prospective study CR

Vincent K et al. 2010Fertil Steril 2010; 93: 62–7

Pain scoring in endometriosis: entry criteria and outcome measures for clinical trials. Report fromthe Art and Science of Endometriosis meeting

CR

Minelli L et al. 2009Arch Surg 2009; 144(3): 234–239

Laparoscopic Colorectal Resection for Bowel Endometriosis: feasibility, complications and clinicaloutcome

CR

Vercellini P et al.Gynecol Obstet Invest 2009; 68: 88–103

Surgery for deep endometriosis: a pathogenesis-oriented approach OS

Slack A et al. 2007BJOG. 2007 Oct;114(10):1278–82

Urological and colorectal complications following surgery for rectovaginal endometriosis CR

Brouwer R et al. 2007ANZ J Surg 2007; 77: 562–571

Rectal endometriosis: results of radical excision and review of published work CR

Ghezzi F et al. 2007Curr Opin Obstet Gynecol. 2007 Aug;19(4):319–24

Management of ureteral endometriosis: areas of controversy OS

Ret Davalos ML et al. 2007J Minim Inv Gynecol 2007;14:33–38

Outcome after rectum or sigmoid resection: a review for gynecologists OS

Gustilo-Ashby AM et al. 2006J Minim Invasive Gynecol. 2006 Nov-Dec;13(6):559–65

Treatment of Urinary tract endometriosis OS

Kennedy S et al. 2005Hum Reprod 2005 Oct;20(10):2698–704

ESHRE guideline for the diagnosis and treatment of endometriosis OS

Emmanuel KR et al. 2005Curr Opin Obstet Gynecol 2005 Aug;17(4):399–402

Outcomes and treatment options in rectovaginal endometriosis CR

Remorgida V et al. 2005Hum Reprod 2005; 20(8): 2317–2320

How complete is full thickness disc resection of bowel endometriotic lesion? A prospective surgicaland histological study

CR

Vignali M et al. 2005J Minim Invasive Gynecol. 2005 Nov-Dec;12(6):508–13

Surgical treatment of deep endometriosis and risk of recurrence CR

Chapron C et al. 2004Ann NY Acad Sci 2004; 1034: 326–337

Surgical Management of DIE: An Update OS

Schindler AE 2004Minerva Ginecol. 2004 Oct;56(5):419–35

Pathophysiology, diagnosis and treatment of endometriosis OS

Donnez J et al. 2004Obstet Gynecol Clin North Am 2004 Sep;31(3):567–80

Laparoscopic excision of deep endometriosis OS

Vercellini P et al. J Am Assoc Gynecol Laparosc 2004May;11(2):153–61

Deep endometriosis: definition, pathogenesis, and clinical management OS

Ford J et al. 2004BJOG. 2004 Apr;111(4):353–6.

Pain, quality of life and complications following the radical resection of rectovaginal endometriosis CR

Chapron C et al. 2003Hum Reprod. 2003 Jan;18(1):157–61

Anatomical distribution of deeply infiltrating endometriosis: surgical implications and propositionfor a classification

OS

Koh CH et al. 2002Curr Opin Obstet Gynecol 2002 Aug;14(4):357–64

The surgical management of deep rectovaginal endometriosis OS

Chapron C et al. 2001Ann N Y Acad Sci 2001 Sep;943:276–80

Management of Deep endometriosis OS

Vercellini P et al. Best Pract Res Clin Obstet Gynaecol2000 Jun;14(3):501–23

Surgical management of endometriosis OS

Verspyck E, et al. Eur J Obstet Gynecol Reprod Biol. 1997 Treatment of bowel endometriosis: a report of six cases of colorectal endometriosis and a surveyofthe literature

OS

Koninckx PR et al. Curr Opin Obstet Gynecol 1994Jun;6(3):231–41

Treatment of Deeply Infiltrating endometriosis OS

OS, original search; ES, extra search in January 2015; CR, cross referencing.

8 Vanhie et al.

Pre-operative information

Deep Endometriosis Surgical Sheet



10 Vanhie et al.

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Description at start of surgery

I General description of all endometriosis lesions:Left side

Location ofendometriosis

Appearance and number of lesions/adhesions* Location ofthe samplecollected§Clear

ARedB

WhiteC

Blue/BlackD

BrownE

VascularF FilmyAdhesion G

DenseAdhesion H

ControlBiopsy

Left pelvic sidewall A A_________

Left utero-sacral ligament A A_________

Left ovary – serosa A A_________

Left tube – serosa A A_________

Others A __ __ __ __ __ __ A_________

Right side


Appearance and number of lesions/adhesions* Location ofthe samplecollected§

ClearA

RedB

WhiteC

Blue/BlackD

BrownE


DenseAdhesion H

ControlBiopsy

Right pelvic sidewall A A_________

Right utero-sacral ligament A A_________

Right ovary – serosa A A_________

Right tube – serosa A A_________

Others A __ __ __ __ __ __ A_________

Central area


Appearance and number of lesions/adhesions* Locationofthe samplecollected§

ClearA

RedB

WhiteC

Blue/BlackD

BrownE


DenseAdhesion H

ControlBiopsy

Uterovesical pouch/ Anteriorcul-de-sac A

A_________

Pouch of Douglas/ Posteriorcul-de-sac A

A_________

Uterus – serosa A A_________

Bladder – deep infiltrating A A_________

Bladder – serosa A A_________

Colon – deep infiltrating A A_________

Colon – serosa A A_________

Vagina A A_________

Others A __ __ __ __ __ __ A_________



II Extent of ovarian endometriosis

III Extent of tubal endometriosis

IV Extent of deep endometriosis:


12 Vanhie et al.

V Additional findings


14 Vanhie et al.

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VI Endometriosis staging

Revised American Fertility Society Score

Peritoneum Endometriosis <1 cm 1–3 cm >3 cm

Superficial 1 A 2 A 4 A

Deep 2 A 4 A 6 A

Ovary Left Superficial 1 A 2 A 4 A

Deep 4 A 16 A 20 A

Right Superficial 1 A 2 A 4 A

Deep 4 A 16 A 20 A

Pouch of Douglasobliteration

Partial Complete

4 A 40 A

Ovary Adhesions <1/3 enclosure 1/3 – 2/3 >2/3 enclosure

Left Filmy 1 A 2 A 4 A

Dense 4 A 8 A 16 A

Right Filmy 1 A 2 A 4 A

Dense 4 A 8 A 16 A

Tube Left Filmy 1 A 2 A 4 A

Dense 4 A* 8 A* 16 A

Right Filmy 1 A 2 A 4 A

Dense 4 A* 8 A* 16 A

*If the fimbriated end of the fallopian tube is completely enclosed, change the point assignment to 16.Mark the total area of endometriosis, possibly of multiple lesions, NOT just the largest lesion.



Endometriosis fertility index


16 Vanhie et al.

ENZIAN-classification (optional)

BB, bilateral involvement; FA, Adenomyosis; FB, bladder involvement; FY, intrinsic involvement of ureter; FI, bowel disease cranial to the sigmoidcolon; FO, other locations.



Description of surgical procedures

I Uterine cavity surgery:

II Ovarian surgery

III Tubal surgery

IV Bowel surgery:


18 Vanhie et al.

V Ureter surgery

VI Bladder surgery



VII Peritoneum surgery

VIII Uterine surgery:

IX Vaginal surgery

X Other procedures

Post-operative information and description

I Operation times

II Intra-operative complications


20 Vanhie et al.

...................................................................................................................................................................................................

Clavien-Dindo classification of surgical complications

Grade Definition

Grade I Any deviation of the normal intra/post-operative course without the need for pharmacological treatment or surgical, endoscopic andradiological interventions.Allowed therapeutic regimens are: drugs as anti-emetics, antipyretics, analgesics, diuretics, electrolytes and physiotherapy.This grade also includes wound infections opened at the bedside

Grade II Requiring pharmacological treatment with drugs other than such allowed for grade IBlood transfusions and TPN are also included

Grade III Requiring surgical, endoscopic or radiological intervention

Grade IIIa Intervention not under general anesthesia

Grade IIIb Intervention under general anesthesia

Grade IV Life-threatening complication (including CNS complications) requiring IC/ICU management

Grade IVa Single organ dysfunction (including dialysis)

Grade IVb Multi-organ dysfunction

Grade V Death of a patient

Suffix D If the patient suffers from a complication at the time of discharge the suffix ‘D’ (for disability) is added to the respective grade of complication.This label indicates the need for a follow-up to fully evaluate the complication

III Detailed description of the abdomen after surgery



Post-operative treatment

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consensus on recording deep endometriosis surgery (cordes) … · †presented at eshre precongress...

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