Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 5:57 AM
Study NCT ID:
NCT07413861
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2025-08-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Natural Orifice Transluminal Endoscopic (vNOTE) Hysterectomy With Uterosacral Suspension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-12', 'studyFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2026-02-12', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal length difference (Delta)', 'timeFrame': 'From intubating to extubating the patient during surgery', 'description': 'The calculated difference in total vaginal length before minus after surgery, evaluated by hysterometer'}], 'secondaryOutcomes': [{'measure': 'Surgery length', 'timeFrame': 'From intubating to extubating the patient during surgery', 'description': 'Surgical length in minutes'}, {'measure': 'Surgical complications', 'timeFrame': 'From intubating to extubating the patient during surgery', 'description': 'Evaluated as a compound parameter including: Excessive bleeding (\\>500 cc), damage to adjacent organ (bladder, bowel, great vessel), change in surgical approach'}, {'measure': 'Visual analog scale (VAS) score', 'timeFrame': 'From immediately after surgery in the post-anesthesia care unit (PACU) until postoperative day 1 (POD1)', 'description': 'Pain will be assessed using a visual analog scale (VAS) ranging from 1 to 10, where 1 represents no pain and 10 represents the worst imaginable pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hysterectomy', 'prevention', 'pelvic prolapse', 'uterosacral suspension', 'vaginal surgery', 'vaginal natural orifice transluminal surgery'], 'conditions': ['Prolapse Pelvic', 'Hysterectomy']}, 'referencesModule': {'references': [{'pmid': '37944925', 'type': 'RESULT', 'citation': 'Martins SB, Castro RA, Takano CC, Marquini GV, Oliveira LM, Martins Junior PCF, Dias MM, Girao MJBC, Sartori MGF. Efficacy of Sacrospinous Fixation or Uterosacral Ligament Suspension for Pelvic Organ Prolapse in Stages III and IV: Randomized Clinical Trial. Rev Bras Ginecol Obstet. 2023 Oct;45(10):e584-e593. doi: 10.1055/s-0043-1772592. Epub 2023 Nov 9.'}, {'pmid': '29038833', 'type': 'RESULT', 'citation': 'Manodoro S, Frigerio M, Milani R, Spelzini F. Tips and tricks for uterosacral ligament suspension: how to avoid ureteral injury. Int Urogynecol J. 2018 Jan;29(1):161-163. doi: 10.1007/s00192-017-3497-y. Epub 2017 Oct 16.'}, {'pmid': '15902153', 'type': 'RESULT', 'citation': 'Aronson MP, Aronson PK, Howard AE, Morse AN, Baker SP, Young SB. Low risk of ureteral obstruction with "deep" (dorsal/posterior) uterosacral ligament suture placement for transvaginal apical suspension. Am J Obstet Gynecol. 2005 May;192(5):1530-6. doi: 10.1016/j.ajog.2004.10.608.'}, {'pmid': '18355787', 'type': 'RESULT', 'citation': 'Altman D, Falconer C, Cnattingius S, Granath F. Pelvic organ prolapse surgery following hysterectomy on benign indications. Am J Obstet Gynecol. 2008 May;198(5):572.e1-6. doi: 10.1016/j.ajog.2008.01.012. Epub 2008 Mar 20.'}, {'pmid': '36818766', 'type': 'RESULT', 'citation': 'Lerner VT, May G, Iglesia CB. Vaginal Natural Orifice Transluminal Endoscopic Surgery Revolution: The Next Frontier in Gynecologic Minimally Invasive Surgery. JSLS. 2023 Jan-Mar;27(1):e2022.00082. doi: 10.4293/JSLS.2022.00082.'}, {'pmid': '31444108', 'type': 'RESULT', 'citation': 'Li CB, Hua KQ. Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) in gynecologic surgeries: A systematic review. Asian J Surg. 2020 Jan;43(1):44-51. doi: 10.1016/j.asjsur.2019.07.014. Epub 2019 Aug 20.'}, {'pmid': '33297354', 'type': 'RESULT', 'citation': 'Housmans S, Noori N, Kapurubandara S, Bosteels JJA, Cattani L, Alkatout I, Deprest J, Baekelandt J. Systematic Review and Meta-Analysis on Hysterectomy by Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared to Laparoscopic Hysterectomy for Benign Indications. J Clin Med. 2020 Dec 7;9(12):3959. doi: 10.3390/jcm9123959.'}]}, 'descriptionModule': {'briefSummary': 'As the adoption of Vaginal natural orifice transluminal endoscopic surgery (vNOTES) expands, attention is shifting from feasibility studies to the refinement of surgical steps that optimize long-term pelvic health.\n\nOne technical distinction between vNOTES hysterectomy and conventional laparoscopic or robotic hysterectomy is the routine early transection of the uterosacral ligaments as the approach is caudal-cephalic. These ligaments are not merely anatomic landmarks-they are the primary apical support structures of the vagina, anchoring the vaginal cuff to the sacrum and providing resistance against downward displacement. Disruption of this support can predispose patients to apical vaginal prolapse, a condition that significantly affects quality of life and may require complex reconstructive surgery.\n\nUterosacral ligament suspension (USLS) is a well-established, effective method of restoring apical support at the time of hysterectomy. Incorporating uterosacral suspension into vNOTES hysterectomy is a logical evolution toward ensuring that minimally invasive innovation does not come at the expense of long-term pelvic health. By adapting and standardizing this reconstructive step for vNOTES, surgeons can maintain apical support, reduce future prolapse risk, and uphold the same quality benchmarks established in laparoscopic and vaginal surgery.\n\nOBJECTIVE AND HYPOTHESIS:\n\nThis study aims to present a practical, reproducible technique for performing USLS in the vNOTES setting and to evaluate its potential immediate benefits, possible complication rates, and additional operative time compared with vNOTES hysterectomy without USLS. In doing so, we seek to demonstrate that preventive pelvic support can be seamlessly integrated without compromising the efficiency or advantages of the transvaginal endoscopic approach.', 'detailedDescription': '1. BACKGROUND AND RATIONALE:\n\n Vaginal natural orifice transluminal endoscopic surgery (vNOTES) is a novel minimally invasive surgical technique that combines the advantages of laparoscopy with a natural orifice approach, eliminating the need for abdominal incisions. By accessing the peritoneal cavity via the vagina, vNOTES offers benefits such as reduced postoperative pain, faster recovery, fewer wound-related complications, and improved cosmetic outcomes. Over the past decade, it has been successfully applied to a broad spectrum of gynecologic procedures, including adnexal surgery and hysterectomy, with growing evidence supporting its safety and feasibility in both benign and complex cases. As the adoption of vNOTES expands, attention is shifting from feasibility studies to the refinement of surgical steps that optimize long-term pelvic health.\n\n One technical distinction between vNOTES hysterectomy and conventional laparoscopic or robotic hysterectomy is the routine early transection of the uterosacral ligaments as the approach is caudal-cephalic. These ligaments are not merely anatomic landmarks-they are the primary apical support structures of the vagina, anchoring the vaginal cuff to the sacrum and providing resistance against downward displacement. Disruption of this support can predispose patients to apical vaginal prolapse, a condition that significantly affects quality of life and may require complex reconstructive surgery. In traditional vaginal or abdominal hysterectomy, preserving or reconstructing apical support is considered standard of care to minimize this risk.\n\n Uterosacral ligament suspension (USLS) is a well-established, effective method of restoring apical support at the time of hysterectomy. Multiple randomized and observational studies have demonstrated that performing USLS prophylactically can significantly reduce the incidence of postoperative vault prolapse, aligning with pelvic reconstructive principles and the American College of Obstetricians and Gynecologists (ACOG) recommendations. Beyond prevention, USLS also improves pelvic floor function, reduces the need for future surgery, and preserves vaginal axis and length. Its application in minimally invasive hysterectomy is now routine in many centers, yet in vNOTES procedures, this important step has not been widely integrated.\n\n Incorporating uterosacral suspension into vNOTES hysterectomy is a logical evolution toward ensuring that minimally invasive innovation does not come at the expense of long-term pelvic health. By adapting and standardizing this reconstructive step for vNOTES, surgeons can maintain apical support, reduce future prolapse risk, and uphold the same quality benchmarks established in laparoscopic and vaginal surgery.\n2. OBJECTIVE AND HYPOTHESIS:\n\nThis study aims to present a practical, reproducible technique for performing USLS in the vNOTES setting and to evaluate its potential immediate benefits, possible complication rates, and additional operative time compared with vNOTES hysterectomy without USLS. In doing so, we seek to demonstrate that preventive pelvic support can be seamlessly integrated without compromising the efficiency or advantages of the transvaginal endoscopic approach.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Females with uterus before hysterectomy planned to be performed by vNOTES surgery for benign indication', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18\n* All women undergoing vNOTES hysterectomy ± Bilateral salpingectomy/salpingo-oopherectomy for benign gynecological indication\n\nExclusion Criteria:\n\n* Exclusion for vNOTES surgery: pelvic inflammatory disease, previous rectal surgery, suspected malignancy, radiation\n* Indication for surgery: elvic prolapse\n* Other surgical interventions planned for the procedure'}, 'identificationModule': {'nctId': 'NCT07413861', 'acronym': 'VENUS', 'briefTitle': 'Vaginal Natural Orifice Transluminal Endoscopic (vNOTE) Hysterectomy With Uterosacral Suspension', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Vaginal Natural Orifice Transluminal Endoscopic (vNOTE) Hysterectomy With Uterosacral Suspension', 'orgStudyIdInfo': {'id': 'HSC-MS-25-0000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hysterectomy by vNOTES approach followed by uterosacral suspension', 'description': 'Two suspension sutures will be placed on the uterosacral ligament on each side after the completion of the hysterectomy', 'interventionNames': ['Procedure: Uterosacral suspension', 'Procedure: Hysterectomy by vNOTES approach']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Hysterectomy by vNOTES approach', 'description': 'No additional intervention will be done following hysterectomy', 'interventionNames': ['Procedure: Hysterectomy by vNOTES approach']}], 'interventions': [{'name': 'Uterosacral suspension', 'type': 'PROCEDURE', 'description': 'Placement of two suspension sutures on the uterosacral ligament on each side', 'armGroupLabels': ['Hysterectomy by vNOTES approach followed by uterosacral suspension']}, {'name': 'Hysterectomy by vNOTES approach', 'type': 'PROCEDURE', 'description': 'Hysterectomy with or without adnexectomy performed by vaginal natural orifice transluminal endoscopic surgery (vNOTES)', 'armGroupLabels': ['Hysterectomy by vNOTES approach', 'Hysterectomy by vNOTES approach followed by uterosacral suspension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Aya Mohr Sasson, MD', 'role': 'CONTACT', 'email': 'aya.mohrsasson@uth.tmc.edu', 'phone': '346-270-4682'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Aya Mohr Sasson', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}