Sacrocolpopexy and Lateral Suspension Operations

NCT04410393 | Active Not Recruiting

• 1 other identifier: ATADEK- 2020/06
• 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 sacrocolpopexy 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

Keywords

sacrocolpopexy; Lateral Suspension

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 Recurrence rate will be defined by pelvic examination according to POP-Q scoring.

  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 ( bleeding rate will be specified in milliliters ) the risk of infection (According to the findings, there is an infection with / without infection.)

  1 years

Study Arms (2)

sacrocolpopexy patients

Patients who underwent sacrocolpopexy 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

lateral suspension surgery patients; sacrocolpopexy 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 sacrocolpopexy 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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pınar Kadiroğulları M.D, Department of Obstetrics and Gynecology,Principal Investigator

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

TU (1)