Sacrospinous Ligament Fixation and Lateral Suspension Operations

Active, not recruiting

• Conditions: Prolapse; Cuff
• Interventions: Procedure: vaginal cuff prolapse surgery

• Registration Number: NCT04072588
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary

Different surgical methods can be used in the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign reasons. One of these is transvaginal sacrospinous ligament fixation and the other is lateral suspension. the investigators want to compare the results of patients undergoing these two operations. Thus, the difference between surgical methods will be investigated.

Detailed Description

Patients with symptomatic vaginal cuff prolapse will be operated; There will be two kinds of operation. After the operations, the patients will be followed up, a questionnaire will be applied to the postoperative patients and some questions will be asked. Pelvic examinations will also be performed and they will be evaluated for recurrence and complication. At the end of the study, the data of both groups will be compared and their superiority to each other will be shown.

Study Timeline

• Study Start: 2019-08-24
• Study First Submitted: 2019-08-24
• Study First Submitted QC: 2019-08-27
• Study First Posted: 2019-08-28
• Primary Completion: 2024-06-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Study Completion: 2026-08-24

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• Patients who had previously undergone hysterectomy for benign causes
• Patients with symptomatic vaginal cuff prolapse during hysterectomy follow-up
• And for this, patients scheduled for operation

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Exclusion Criteria

• Patients with chronic diseases or medications that interfere with the operation
• Patients with oncology operated for malignant cause
• Non-localized patients with vaginal cuff prolapse

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sacrospinous Ligament Fixation patients	vaginal cuff prolapse surgery	Patients who underwent Sacrospinous Ligament Fixation for the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign causes
lateral suspension surgery patients	vaginal cuff prolapse surgery	Patients who underwent lateral suspension surgery for vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign causes

Primary Outcome Measures

Name	Time	Method
recurrence	1 years	Patients will be followed up for 1 year after surgery and will be evaluated for recurrence at 1, 6 and 12 months.; degree of uterine desensus cystocele and rectocele degree to be examined
complications	1 years	Patients will be followed up for 1 year after the operation and will be evaluated for complications at 1, 6 and 12 months.; bleeding the risk of infection and recurrence

Trial Locations

Locations (1)

Kanuni Sultan Süleyman Training and Research Hospital; 🇹🇷 Istanbul, Turkey