Post-hysterectomy Vaginal Cuff Prolapse Repair

Официальное название

Laparoscopic Lateral Suspension Versus Laparoscopic Sacrocolpopexy for Post-Hysterectomy Vaginal Cuff Prolapse: A Randomized Controlled Trial

Обзор

This study is a randomized controlled trial comparing two minimally invasive surgeries-laparoscopic lateral suspension and laparoscopic sacrocolporopexy-for women who develop vaginal cuff prolapse after hysterectomy. Vaginal cuff prolapse occurs when the top of the vagina loses support after the uterus is removed, which can cause discomfort, bulging, or urinary and bowel problems. 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.

Подробное описание

This study is a randomized controlled trial (RCT) designed to compare the outcomes of two minimally invasive surgical techniques-laparoscopic lateral suspension and laparoscopic sacrocolpopexy-for the treatment of vaginal cuff prolapse following hysterectomy. Vaginal cuff prolapse occurs when the top of the vagina loses its normal support after the uterus has been removed, leading to symptoms such as a sensation of vaginal bulging, pelvic pressure, urinary or bowel dysfunction, and discomfort during daily activities or sexual intercourse.

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Anatomical Success (Point C of POP-Q System) [Срок оценки: 12 months post-surgery]

Вторичные конечные точки (6)

• Operative Time [Срок оценки: During surgery]
• Postoperative Hospital Stay [Срок оценки: From the day of surgery through hospital discharge (an expected average of 2 days)]
• Postoperative Complications [Срок оценки: Up to 12 months post-surgery]
• Pelvic Floor Distress Inventory (PFDI-20) [Срок оценки: Preoperative and 12 months post-surgery]
• Pelvic Floor Impact Questionnaire (PFIQ-7) [Срок оценки: Preoperative and 12 months post-surgery]
• Patient Global Impression (PGI) Scale [Срок оценки: Preoperative and 12 months post-surgery]

Критерии участия

Критерии включения

Women aged ≥18 years.

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.

Критерии исключения

Prior sacrocolpopexy or lateral suspension surgery.

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Basaksehir Cam and Sakura City Hospital — Istanbul

Идентификаторы

NCT: NCT07174921 · CSC Hospital

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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