Sacro-Spinous Ligaments Anterior Apical Anchoring

Sacro-Spinous Ligaments Anterior Apical Anchoring for Needle-Guided Mesh in Advanced Pelvic Organ Prolapse

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Anterior Sacro-Spinous

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 Type: Observational
• Enrollment (Actual): 44

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Female patients suffering advanced pelvic organ prolapse with anterior predominance and apical supportive defect, reffered to mesh reconstruction.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Active Pelvic Inflammation,
• Patient Refusal

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Anterior Sacro-Spinous Support; Anterior sacro-spinous mesh implants supported patients	Procedure: Anterior Sacro-Spinous; Anterior Sacro-Spinous

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya
• Investigators: Principal Investigator: Menahem Neuman, Prof., Western Galilee MC

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: April 24, 2013
• First Submitted That Met QC Criteria: April 26, 2013
• First Posted (Estimate): April 29, 2013

Study Record Updates

• Last Update Posted (Estimate): June 19, 2015
• Last Update Submitted That Met QC Criteria: June 17, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: WesternGalileeH