Sacro-Spinous Ligaments Anterior Apical Anchoring

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Anterior Sacro-Spinous

• Registration Number: NCT01842464
• Lead Sponsor: Western Galilee Hospital-Nahariya

Brief Summary

Anterior-apical compartment mesh implants for pelvic floor reconstruction are anchored here to the Sacro-Spinous ligaments and evaluated being a feasible and effective method.

Detailed Description

Anterior-apical compartment mesh implants for pelvic floor reconstruction are frequently anchored to the Arcus Tendinous Fascia Pelvis (ATFP) rather than to the Sacro-Spinous (SS) ligaments commonly used for the posterior compartment reconstruction. The SS ligament suspension for apical support mesh fixation is thought to yield higher and stronger anchoring point than the ATFP. The authors presumed that anterior mesh fixation to the sacro-spinous ligament are both, feasible and effective.

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2011-12
• Study Completion: 2012-01
• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-04-26
• Study First Posted: 2013-04-29
• Results First Submitted: 2013-07-31
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-17
• Last Update Submitted: 2015-06-17
• Results First Posted: 2015-06-19
• Last Update Posted: 2015-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

• Pelvic Floor Prolapse > Gr 2,
• Anterior > Posterior defect,
• Apical Supportive Defect

Exclusion Criteria

• Active Pelvic Inflammation,
• Patient Refusal

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Anterior Sacro-Spinous Support	Anterior Sacro-Spinous	Anterior sacro-spinous mesh implants supported patients

Primary Outcome Measures

Name	Time	Method
Efficacy of Sacro-Spinous Ligaments Anterior Apical Anchoring	one year	Level of support with the Sacro-Spinous Ligaments Anterior Apical Anchoring higher than 4 centimeters above vaginal opening.
Number of Participants Involving in Complications: Operative Damage and Bleeding, Post Operative Infection and Mesh Exposure	one year	Number of participants involving in complications: operative damage and bleeding, post operative infection and mesh exposure.
The Change With Distance Between the Vaginal Apex and the Introitus	One year	The change with distance measured by centimeters, between the vaginal apex and the introitus