Modified Technique in Sacrospinous Fixation for Treatment of Apical Genital Prolapse

January 19, 2023 updated by: Ahmed Mohamed Abbas, Assiut University

A Modified Technique in Sacrospinous Fixation Using Posterior Vaginal Wall Flap for Treatment of Apical Genital Prolapse

Pelvic organ prolapse is one of the most common benign gynecological disorders and affects approximately 40% of women over 50 years of age. The causes of utero vaginal prolapse are pregnancy, labor, obesity, increased intra-abdominal pressure, and weak pelvic floor structures

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

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

Study Contact

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

patients with symptomatic Stage II , III and Stage IV Apical Prolapse (diagnosed by pop Q test)

Description

Inclusion Criteria:

1- Symptomatic Stage II , III and Stage IV Apical Prolapse (diagnosed by pop Q test ) .

Exclusion Criteria:

  1. Patients with medical disorders that may interfere with surgical interventions ( Like severe chest and heart diseases , renal and liver cell failure , bleeding tendency ) .
  2. Patients with urinary incontinence ( excluded by history , examination & Urodynamics)

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study group
patients with symptomatic Stage II , III and Stage IV Apical Prolapse (diagnosed by pop Q test)
Procedure: sacrospinous fixation Using Posterior Vaginal wall flap
  • Identification of the sacro spinous ligament.
  • Insertion of the sacrospinous stitch. Using a long - handled needle holder, a J - shaped Ethibond suture is placed 2 - 3 cm medial to the right ischial spine. Using posterior vaginal wall flap (rectangular flap )will be incised and retracted Superior to the right , the stitch of sacro spinous ligament will be attached to the flap not the vault after adjusting its size , then the sit . The stitch should be placed through and not around the ligament. The application of firm traction to the suture length will test the correctness of its placement. A second suture is inserted for additional support. We may do it directly or by using an alternative surgical instruments for placement of the suture include the knee scorpion. Per rectum examination should be undertaken to check for misplaced sutures.
  • Attachment of the sutures to the vaginal flap . The two sutures are then secured to the upper posterior aspect of the vaginal flap ,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The difference of quality life score
Time Frame: 6 months
this will be assessed before and after the surgery using
6 months

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

February 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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