[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583442":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":32,"studyPopulation":33,"armGroups":34,"interventions":39,"overallOfficials":28,"centralContacts":44,"locations":54,"responsibleParty":77,"collaborators":28,"id":79,"slug":28,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":28,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":28,"enrollmentInfo":87,"targetDuration":28,"studyType":90,"phases":28,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":57,"whyStopped":28,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Fundacion Dexeus","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":28},[9,13],{"measure":10,"description":11,"timeFrame":12},"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",{"measure":14,"description":15,"timeFrame":12},"Accuracy of intraoperative ultrasound","o Agreement between intraoperative ultrasound findings and histopathological results regarding the depth of infiltration and size of bowel DIE nodules.",[17,20,24],{"measure":18,"description":19,"timeFrame":12},"Impact on Surgical Decision-Making","o Changes in surgical strategy (shaving, discoid excision, or segmental resection) based on intraoperative ultrasound findings.",{"measure":21,"description":22,"timeFrame":23},"Postoperative Pain and Function","Improvement in pain symptoms and quality of life","at 3-months, 6-months and 12-months follow-up",{"measure":25,"description":26,"timeFrame":27},"Complication Rates","o Frequency of intraoperative or postoperative complications (ClassIntra and Clavien-Dindo ≥ III).","From day of surgery to 7 days later",null,{"allocation":28,"interventionModel":28,"interventionModelDescription":28,"primaryPurpose":28,"observationalModel":30,"timePerspective":31,"maskingInfo":28},"COHORT","PROSPECTIVE","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.","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.",[35],{"label":36,"type":28,"description":28,"interventionNames":37},"posterior compartment deep infiltrating endometriosis",[38],"Procedure: intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosis",[40],{"type":41,"name":42,"description":33,"armGroupLabels":43,"otherNames":28},"PROCEDURE","intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosis",[36],[45,50],{"name":46,"role":47,"phone":48,"phoneExt":28,"email":49},"Yannick Hurni, MD","CONTACT","0034932274700","yanhur@dexeus.com",{"name":51,"role":47,"phone":48,"phoneExt":52,"email":53},"Ignacio Rodríguez, MSc","22029","nacrod@dexeus.com",[55],{"facility":56,"status":57,"city":58,"state":28,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus","RECRUITING","Barcelona","08037","Spain","ES",{"type":63,"coordinates":64},"Point",[65,66],2.15899,41.38879,{"lat":66,"lon":65},[69,71,73,75],{"name":70,"role":47,"phone":48,"phoneExt":52,"email":53},"Ignacio Rodríguez, BsC",{"name":46,"role":72,"phone":28,"phoneExt":28,"email":28},"PRINCIPAL_INVESTIGATOR",{"name":74,"role":72,"phone":28,"phoneExt":28,"email":28},"Pere N Barri-Soldevila, MD",{"name":76,"role":72,"phone":28,"phoneExt":28,"email":28},"Nuria Barbany-Freixa, MD",{"type":78,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100583442",false,"NCT06876376","Intraoperative Ultrasound in Bowel Deep Endometriosis","Intraoperative Transvaginal and Endorectal Ultrasound for the Assessment of Bowel Deep Infiltrating Endometriosis","Inclusion Criteria:\n\n* Preoperative sonographic and\u002For MRI findings suggestive of bowel DIE (uterosacral ligaments, posterior vaginal wall, parametrium, retrocervical area, rectovaginal septum, rectum, and\u002For sigmoid colon).\n* Scheduled for surgical treatment (laparoscopy or robot-assisted laparoscopy).\n* Planned postoperative follow-up for at least 12 months.\n* Written informed consent provided before surgery.\n\nExclusion Criteria:\n\n* Planned surgery for diagnostic purposes only.\n* Pregnancy at the time of enrollment.\n* Poor understanding of Spanish or English.","FEMALE","18 Years",{"count":88,"type":89},200,"ESTIMATED","OBSERVATIONAL","This study investigates the use of intraoperative transvaginal (IOTVUS) and\u002For endorectal ultrasound (IOERUS) in the surgical treatment of bowel deep infiltrating endometriosis (DIE).",[93],"Deep Infiltrating Endometriosis With or Without Bowel Involvement",[95,96,97,98,99],"Endometriosis","Intraoperative Ultrasound","Ultrasound","surgery","minimally invasive surgery","2026-03-25",{"date":102,"type":103},"2026-03-30","ACTUAL",{"date":105,"type":103},"2025-01-20",{"date":107,"type":89},"2027-06",{"name":5,"class":6},1]