Post-hysterectomy Vaginal Cuff Prolapse Repair

NCT07174921 | Recruiting DMC

• 1 other identifier: CSC Hospital
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaginal Cuff Complications

Keywords

prolapse; vaginal cuff; lateral suspension; sacrocolpopexy

Outcome Measures

Primary Outcomes (1)

• Anatomical Success (Point C of POP-Q System)

  Vaginal cuff support measured objectively using POP-Q system, focusing on point C (position of the vaginal apex relative to the hymen). Success is defined as point C remaining above the hymen at follow-up by a blinded examiner.

  12 months post-surgery

Secondary Outcomes (6)

• Operative Time

  During surgery

• Postoperative Hospital Stay

  From the day of surgery through hospital discharge (an expected average of 2 days)

• Postoperative Complications

  Up to 12 months post-surgery

• Pelvic Floor Distress Inventory (PFDI-20)

  Preoperative and 12 months post-surgery

• Pelvic Floor Impact Questionnaire (PFIQ-7)

  Preoperative and 12 months post-surgery

Study Arms (2)

Laparoscopic Sacrocolpopexy

ACTIVE COMPARATOR

Procedure: Laparoscopic Sacrocolpopexy

Laparoscopic Lateral Suspension

EXPERIMENTAL

Procedure: Laparoscopic Lateral Suspension

Interventions

Laparoscopic Lateral Suspension PROCEDURE

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.

Also known as: Lateral Suspension (Apical Suspension)

Laparoscopic Lateral Suspension

Laparoscopic Sacrocolpopexy PROCEDURE

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 Sacrocolpopexy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Basaksehir Cam and Sakura City Hospital

Istanbul, Istanbul, 34494, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ozan Karadeniz, MD

CONTACT

+905333663003; dr.ozankrdnz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 7, 2025
• First Posted: September 16, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

TU (1)