Sacrospinous Ligament Fixation and Lateral Suspension Operations

July 17, 2024 updated by: Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital

Comparison of Transvaginal Sacrospinous Ligament Fixation and Lateral Suspension Operations in the Treatment of Vaginal Cuff Prolapse in Hysterectomized Patients

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 33404
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Different surgical methods for the treatment of vaginal cuff prolapse in patients who have previously undergone hysterectomy for benign causes
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
Different surgical methods for the treatment of vaginal cuff prolapse in patients who have previously undergone hysterectomy for benign causes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence
Time Frame: 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
1 years
complications
Time Frame: 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
1 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2019

Primary Completion (Actual)

June 24, 2024

Study Completion (Estimated)

August 24, 2026

Study Registration Dates

First Submitted

August 24, 2019

First Submitted That Met QC Criteria

August 27, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 17, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019.04.110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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