A Vanhie1, C Meuleman1, C Tomassetti1, D Timmerman1, A D'Hoore2, A Wolthuis2, B Van Cleynenbreugel3, E Dancet1, 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, E Zupi16, L Minelli9, M Cooper17, G Dunselman18, C Koh19, M S Abrao20, C Chapron21, T D'Hooghe22. 1. Department of Obstetrics and Gynecology, University Hospital Leuven, Leuven, Belgium. 2. Department of Abdominal Surgery, University Hospital Leuven, Leuven, Belgium. 3. Department of Urology, University Hospital Leuven, Leuven, Belgium. 4. Monash Health and Monash University, Melbourne, VIC, Australia. 5. Frauenklinik, Universitaetsklinikum Erlangen, Erlangen, Germany. 6. Praxis für Frauengesundheit, Gynäkologie und Geburtshilfe, Berlin, Germany. 7. Service of Gynecology, Hospital Clinic of Barcelona, University of Barcelona, Barcelona, Spain. 8. Royal Hospital for Women and University of New South Wales, Sydney, Australia. 9. Department of Obstetrics and Gynecology, Ospedale Sacro Cuore, Verona, Italy. 10. Yale School of Medicine, New Haven, CT, USA. 11. University College London Hospitals, London, UK. 12. Universitätsklinik für Frauenheilkunde, Universitätsspital Bern, Bern, Switzerland. 13. Landeskrankenanstalten-Betriebsgesellschaft (KABEG) and Landeskrankenhaus Villach, Abteilung für Gynäkologie und Geburtshilfe, Villach, Austria. 14. Department of Obstetrics and Gynecology, University Hospital of Geneva, Geneva, Switzerland. 15. Reproductive Specialty Center, Columbia St. Mary's Hospital, Milwaukee, WI, USA Medical College of Wisconsin, Milwaukee, WI, USA. 16. University of Siena, Siena, Italy. 17. Department of Obstetrics and Gynaecology, Sydney University, Sydney, Australia. 18. Department of Obstetrics & Gynaecology, Research Institute GROW, Maastricht, The Netherlands University Medical Centre, PO Box 5800, 6202 AZ Maastricht, The Netherlands. 19. Milwaukee Institute of Minimally Invasive Surgery, Milwaukee, WI, USA. 20. Division of Reproductive Medicine, Sirio Libanes Hospital, Sao Paulo, Brazil Division of Endometriosis, Department of Obstetrics and Gynaecology, São Paulo University, São Paulo, Brazil. 21. Faculty of Medicine, Université Paris Descartes, Sorbonne Paris Cité, Paris, France Department of Gynecology, Obstetrics, and Reproductive Medicine, Centre Hospitalier Universitaire Cochin of the Groupe Hospitalier Universitaire Ouest, Paris, France. 22. Department of Obstetrics and Gynecology, University Hospital Leuven, Leuven, Belgium Faculty of Medicine, Leuven University, Leuven, Belgium Faculty of Medicine, Yale University, New Haven, CT, USA thomas.dhooghe@med.kuleuven.be.
Abstract
STUDY QUESTION: Which essential items should be recorded before, during and after endometriosis surgery and in clinical outcome based surgical trials in patients with deep endometriosis (DE)? SUMMARY ANSWER: A DE surgical sheet (DESS) was developed for standardized reporting of the surgical treatment of DE and an international expert consensus proposal on relevant items that should be recorded in surgical outcome trials in women with DE. WHAT IS KNOWN ALREADY: Surgery is an important treatment for symptomatic DE. So far, data have been reported in such a way that comparison of different surgical techniques is impossible. Therefore, we present an international expert proposal for standardized reporting of surgical treatment and surgical outcome trials in women with DE. STUDY DESIGN, SIZE, DURATION: International expert consensus based on a systematic review of literature. PARTICIPANTS/MATERIALS, SETTING, METHODS: Taking into account recommendations from Consolidated Standards of Reporting Trials (CONSORT), the Innovation Development Exploration Assessment and Long-term Study (IDEAL), the Initiative on Methods, Measurement and Pain Assessment in Clinical trials (IMMPACT) and the World Endometriosis Research Foundation Phenome and Biobanking Harmonisation Project (WERF EPHect), a systematic literature review on surgical treatment of DE was performed and resulted in a proposal for standardized reporting, adapted by contributions from eight members of the multidisciplinary Leuven University Hospitals Endometriosis Care Program, from 18 international experts and from audience feedback during three international meetings. MAIN RESULTS AND THE ROLE OF CHANCE: We have developed the DESS to record in detail the surgical procedures for DE, and an international consensus on pre-, intra- and post-operative data that should be recorded in surgical outcome trials on DE. LIMITATIONS, REASONS FOR CAUTION: The recommendations in this paper represent a consensus among international experts based on a systematic review of the literature. For several items and recommendations, high-quality RCTs were not available. Further research 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 in women with DE, based on a systematic literature review and international consensus, can be used as a guideline to record and report surgical management of patients with DE and as a guideline to design, execute, interpret and compare clinical trials in this patient population. STUDY FUNDING/COMPETING INTERESTS: None of the authors received funding for the development of this paper. M.A. reports personal fees and non-financial support from Bayer Pharma outside the submitted work; H.T. reports a grant from Pfizer and personal fees for being on the advisory board of Perrigo, Abbvie, Allergan and SPD. TRIAL REGISTRATION NUMBER: N/A.
STUDY QUESTION: Which essential items should be recorded before, during and after endometriosis surgery and in clinical outcome based surgical trials in patients with deep endometriosis (DE)? SUMMARY ANSWER: A DE surgical sheet (DESS) was developed for standardized reporting of the surgical treatment of DE and an international expert consensus proposal on relevant items that should be recorded in surgical outcome trials in women with DE. WHAT IS KNOWN ALREADY: Surgery is an important treatment for symptomatic DE. So far, data have been reported in such a way that comparison of different surgical techniques is impossible. Therefore, we present an international expert proposal for standardized reporting of surgical treatment and surgical outcome trials in women with DE. STUDY DESIGN, SIZE, DURATION: International expert consensus based on a systematic review of literature. PARTICIPANTS/MATERIALS, SETTING, METHODS: Taking into account recommendations from Consolidated Standards of Reporting Trials (CONSORT), the Innovation Development Exploration Assessment and Long-term Study (IDEAL), the Initiative on Methods, Measurement and Pain Assessment in Clinical trials (IMMPACT) and the World Endometriosis Research Foundation Phenome and Biobanking Harmonisation Project (WERF EPHect), a systematic literature review on surgical treatment of DE was performed and resulted in a proposal for standardized reporting, adapted by contributions from eight members of the multidisciplinary Leuven University Hospitals Endometriosis Care Program, from 18 international experts and from audience feedback during three international meetings. MAIN RESULTS AND THE ROLE OF CHANCE: We have developed the DESS to record in detail the surgical procedures for DE, and an international consensus on pre-, intra- and post-operative data that should be recorded in surgical outcome trials on DE. LIMITATIONS, REASONS FOR CAUTION: The recommendations in this paper represent a consensus among international experts based on a systematic review of the literature. For several items and recommendations, high-quality RCTs were not available. Further research 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 in women with DE, based on a systematic literature review and international consensus, can be used as a guideline to record and report surgical management of patients with DE and as a guideline to design, execute, interpret and compare clinical trials in this patient population. STUDY FUNDING/COMPETING INTERESTS: None of the authors received funding for the development of this paper. M.A. reports personal fees and non-financial support from Bayer Pharma outside the submitted work; H.T. reports a grant from Pfizer and personal fees for being on the advisory board of Perrigo, Abbvie, Allergan and SPD. TRIAL REGISTRATION NUMBER: N/A.
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