Modified Technique in Sacrospinous Fixation for Treatment of Apical Genital Prolapse

NCT ID: NCT05691543

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 15 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-28
• Study Completion Date: 2025-12-31

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

study group

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

sacrospinous fixation Using Posterior Vaginal wall flap

Intervention Type: 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 ,

Interventions

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 ,

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Abbas

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Gehad Zaky, MSc

Role: CONTACT

gehadzaky@yahoo.com

00201018561298

Other Identifiers

SSF

Identifier Type: -

Identifier Source: org_study_id