Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2025-09-30
2026-10-15
Brief Summary
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The goal of this study is to determine which surgical approach is safer, more effective, and improves quality of life for patients. Women enrolled in the trial will be randomly assigned to one of the two surgeries, and outcomes such as prolapse recurrence, complications, recovery time, and patient satisfaction will be carefully monitored.
By comparing these two techniques, this study aims to provide clear guidance for surgeons and patients to make informed decisions about the best surgical treatment for post-hysterectomy vaginal cuff prolapse.
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Detailed Description
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Eligible participants are women who have previously undergone hysterectomy and are experiencing symptomatic vaginal cuff prolapse. Participants will be randomly assigned to undergo either laparoscopic lateral suspension or laparoscopic sacrocolpopexy. Both procedures are performed using minimally invasive laparoscopic techniques, which typically result in smaller incisions, less pain, and faster recovery compared to traditional open surgery.
The study will assess multiple clinical and patient-reported outcomes, including:
Anatomical success: Prevention of prolapse recurrence at follow-up visits.
Functional outcomes: Improvement in urinary, bowel, and sexual function.
Complications: Intraoperative and postoperative adverse events.
Recovery metrics: Length of hospital stay, return to daily activities, and postoperative pain.
Patient satisfaction: Quality of life and overall satisfaction with the procedure.
By conducting this study, researchers aim to provide evidence-based guidance on which surgical approach offers better long-term outcomes, fewer complications, and higher patient satisfaction. The results of this trial may help clinicians make informed decisions and improve the care of women with post-hysterectomy vaginal cuff prolapse.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Laparoscopic Sacrocolpopexy
Laparoscopic Sacrocolpopexy
Participants in this arm will undergo laparoscopic sacrohysteropexy for post-hysterectomy vaginal cuff prolapse. The procedure involves suspending the vaginal cuff to the sacral promontory using a synthetic mesh, restoring vaginal support. Standard perioperative care, including anesthesia and postoperative pain management, will be provided.
Laparoscopic Lateral Suspension
Laparoscopic Lateral Suspension
Participants in this arm will undergo laparoscopic lateral suspension for post-hysterectomy vaginal cuff prolapse. The procedure involves attaching a synthetic mesh from the vaginal cuff to the lateral abdominal wall to provide support and restore normal vaginal anatomy. Standard perioperative care, including anesthesia and postoperative pain management, will be provided.
Interventions
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Laparoscopic Lateral Suspension
Participants in this arm will undergo laparoscopic lateral suspension for post-hysterectomy vaginal cuff prolapse. The procedure involves attaching a synthetic mesh from the vaginal cuff to the lateral abdominal wall to provide support and restore normal vaginal anatomy. Standard perioperative care, including anesthesia and postoperative pain management, will be provided.
Laparoscopic Sacrocolpopexy
Participants in this arm will undergo laparoscopic sacrohysteropexy for post-hysterectomy vaginal cuff prolapse. The procedure involves suspending the vaginal cuff to the sacral promontory using a synthetic mesh, restoring vaginal support. Standard perioperative care, including anesthesia and postoperative pain management, will be provided.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
History of hysterectomy (any approach: abdominal, vaginal, or laparoscopic).
Symptomatic vaginal cuff prolapse (POP-Q stage ≥ II).
Able to provide written informed consent.
Willing and able to comply with study procedures and follow-up visits.
Exclusion Criteria
Active pelvic infection or untreated malignancy.
Severe cardiopulmonary or systemic disease that contraindicates laparoscopic surgery.
Known allergy to mesh materials used in the procedures.
Inability to complete patient-reported questionnaires due to cognitive or language barriers.
Concurrent pelvic organ prolapse requiring additional surgical repair beyond vaginal cuff suspension.
18 Years
FEMALE
No
Sponsors
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Kanuni Sultan Suleyman Training and Research Hospital
OTHER
Responsible Party
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Ozan Karadeniz
Principal Investigator
Locations
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Basaksehir Cam and Sakura City Hospital
Istanbul, Istanbul, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CSC Hospital
Identifier Type: -
Identifier Source: org_study_id
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