Sacrospinous Ligament Fixation and Lateral Suspension Operations

NCT04072588 | Active Not Recruiting

• 1 other identifier: 2019.04.110
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Prolapse; Cuff

Outcome Measures

Primary Outcomes (2)

• recurrence

  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

  1 years

• complications

  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

  1 years

Study Arms (2)

Sacrospinous Ligament Fixation patients

Patients who underwent Sacrospinous Ligament Fixation for the treatment of vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign causes

Procedure: vaginal cuff prolapse surgery

lateral suspension surgery patients

Patients who underwent lateral suspension surgery for vaginal cuff prolapse in patients who had previously undergone hysterectomy for benign causes

Procedure: vaginal cuff prolapse surgery

Interventions

vaginal cuff prolapse surgery PROCEDURE

Different surgical methods for the treatment of vaginal cuff prolapse in patients who have previously undergone hysterectomy for benign causes

Sacrospinous Ligament Fixation patients; lateral suspension surgery patients

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 will form study groups of patients who underwent these two operations.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prolapse

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pınar kadiroğulları M.D, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: August 24, 2019
• First Posted: August 28, 2019
• Study Start: August 24, 2019
• Primary Completion: June 24, 2024
• Study Completion (Estimated): August 24, 2026
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

TU (1)