Modified Technique in Sacrospinous Fixation for Treatment of Apical Genital Prolapse

Genital Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05691543
• Other study ID #: SSF
• Status: Not yet recruiting
• Start date: February 2023
• Est. completion date: December 2025

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: Gehad Zaky, MSc
• Phone: 00201018561298
• Email: gehadzaky[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Genital Prolapse
• Prolapse

Intervention

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 ,

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference of quality life score	this will be assessed before and after the surgery using	6 months