Modified Technique in Sacrospinous Fixation for Treatment of Apical Genital Prolapse

NCT05691543 | Unknown

• 1 other identifier: SSF
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Genital Prolapse

Outcome Measures

Primary Outcomes (1)

• The difference of quality life score

  this will be assessed before and after the surgery using

  6 months

Study Arms (1)

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

Interventions

sacrospinous fixation Using Posterior Vaginal wall flap PROCEDURE

* 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 ,

study group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Central Study Contacts

Gehad Zaky, MSc

CONTACT

00201018561298; gehadzaky@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 20, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share