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This study investigates the use of intraoperative transvaginal (IOTVUS) and/or endorectal ultrasound (IOERUS) in the surgical treatment of bowel deep infiltrating endometriosis (DIE).
Bowel DIE is a severe form of endometriosis that often infiltrates the rectum and the sigmoid colon, requiring precise surgical techniques to achieve complete excision while minimizing unnecessary resections of healthy tissues and organs. Current preoperative imaging techniques, such as transvaginal ultrasound and magnetic resonance imaging, are often limited in their ability to assess lesion depth and extent in cases of severe pelvic anatomical distortion. Intraoperative ultrasound offers a real-time evaluation after rectal mobilization, allowing for a more accurate assessment of lesion location, depth, and bowel wall infiltration. The primary objectives are to evaluate the feasibility and accuracy of intraoperative ultrasound in detecting rectal and RSJ DIE nodules and to guide surgical decision-making. Secondary objectives include determining the impact of these techniques on surgical outcomes, postoperative pain management, and quality of life. The goal is to enhance surgical decision-making by accurately assessing lesion depth and location, potentially reducing unnecessary colorectal resections or avoiding inadvertent retention of endometrial nodules. Participants will complete health and pain questionnaires preoperatively and at 3, 6, and 12 months postoperatively, evaluating dysmenorrhea, dyspareunia, dyschezia, and quality of life using validated tools. The study will also document intraoperative findings, surgical decisions, complications, and postoperative outcomes. By combining IOTVUS and IOERUS with existing surgical approaches, this study seeks to establish these techniques as standard tools for improving surgical precision in bowel DIE cases. Results could provide valuable insights for tailoring interventions to patient-specific disease presentations, enhancing long-term management strategies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| posterior compartment deep infiltrating endometriosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosis | Procedure | Women with posterior compartment deep infiltrating endometriosis with or without bowel involvement scheduled for surgical treatment at the Department of Obstetrics, Gynecology, and Reproductive Medicine of Dexeus University Hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of intraoperative ultrasound | o The proportion of patients in whom intraoperative ultrasound techniques can successfully identify rectal or rectosigmoid junction deep infiltrating endometriosis nodules during surgery. | Day of surgery |
| Accuracy of intraoperative ultrasound | o Agreement between intraoperative ultrasound findings and histopathological results regarding the depth of infiltration and size of bowel DIE nodules. | Day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Impact on Surgical Decision-Making | o Changes in surgical strategy (shaving, discoid excision, or segmental resection) based on intraoperative ultrasound findings. | Day of surgery |
| Postoperative Pain and Function |
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Inclusion Criteria:
Exclusion Criteria:
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Women with posterior compartment deep infiltrating endometriosis with or without bowel involvement scheduled for surgical treatment at the Department of Obstetrics, Gynecology, and Reproductive Medicine of Dexeus University Hospital.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yannick Hurni, MD | Contact | 0034932274700 | yanhur@dexeus.com | |
| Ignacio Rodríguez, MSc | Contact | 0034932274700 | 22029 | nacrod@dexeus.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus | Recruiting | Barcelona | 08037 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15541453 | Background | Giudice LC, Kao LC. Endometriosis. Lancet. 2004 Nov 13-19;364(9447):1789-99. doi: 10.1016/S0140-6736(04)17403-5. | |
| 15947176 | Background | Berkley KJ, Rapkin AJ, Papka RE. The pains of endometriosis. Science. 2005 Jun 10;308(5728):1587-9. doi: 10.1126/science.1111445. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
Improvement in pain symptoms and quality of life
| at 3-months, 6-months and 12-months follow-up |
| Complication Rates | o Frequency of intraoperative or postoperative complications (ClassIntra and Clavien-Dindo ≥ III). | From day of surgery to 7 days later |
| 20801404 | Background | de Ziegler D, Borghese B, Chapron C. Endometriosis and infertility: pathophysiology and management. Lancet. 2010 Aug 28;376(9742):730-8. doi: 10.1016/S0140-6736(10)60490-4. |
| 21718982 | Background | Nnoaham KE, Hummelshoj L, Webster P, d'Hooghe T, de Cicco Nardone F, de Cicco Nardone C, Jenkinson C, Kennedy SH, Zondervan KT; World Endometriosis Research Foundation Global Study of Women's Health consortium. Impact of endometriosis on quality of life and work productivity: a multicenter study across ten countries. Fertil Steril. 2011 Aug;96(2):366-373.e8. doi: 10.1016/j.fertnstert.2011.05.090. Epub 2011 Jun 30. |
| 24366116 | Background | Vercellini P, Vigano P, Somigliana E, Fedele L. Endometriosis: pathogenesis and treatment. Nat Rev Endocrinol. 2014 May;10(5):261-75. doi: 10.1038/nrendo.2013.255. Epub 2013 Dec 24. |
| 16543256 | Background | Chapron C, Chopin N, Borghese B, Foulot H, Dousset B, Vacher-Lavenu MC, Vieira M, Hasan W, Bricou A. Deeply infiltrating endometriosis: pathogenetic implications of the anatomical distribution. Hum Reprod. 2006 Jul;21(7):1839-45. doi: 10.1093/humrep/del079. Epub 2006 Mar 16. |
| 21241258 | Background | Scioscia M, Bruni F, Ceccaroni M, Steinkasserer M, Stepniewska A, Minelli L. Distribution of endometriotic lesions in endometriosis stage IV supports the menstrual reflux theory and requires specific preoperative assessment and therapy. Acta Obstet Gynecol Scand. 2011 Feb;90(2):136-9. doi: 10.1111/j.1600-0412.2010.01008.x. Epub 2010 Dec 2. |
| 29202966 | Background | Donnez O, Roman H. Choosing the right surgical technique for deep endometriosis: shaving, disc excision, or bowel resection? Fertil Steril. 2017 Dec;108(6):931-942. doi: 10.1016/j.fertnstert.2017.09.006. |
| 31238150 | Background | Abrao MS, Andres MP, Barbosa RN, Bassi MA, Kho RM. Optimizing Perioperative Outcomes with Selective Bowel Resection Following an Algorithm Based on Preoperative Imaging for Bowel Endometriosis. J Minim Invasive Gynecol. 2020 May-Jun;27(4):883-891. doi: 10.1016/j.jmig.2019.06.010. Epub 2019 Jun 22. |
| 32991006 | Background | Puppo A, Olearo E, Gattolin A, Rimonda R, Novelli A, Ceccaroni M. Intraoperative Ultrasound for Bowel Deep Infiltrating Endometriosis: A Preliminary Report. J Ultrasound Med. 2021 Jul;40(7):1417-1425. doi: 10.1002/jum.15511. Epub 2020 Sep 29. |
| D000091662 | Genital Diseases |