NCT01348334

Synthetic Mesh Materials In Sling Surgery

Use Of Three Types Of Synthetic Mesh Materials In Sling Surgery: A Prospective Randomized Clinical Trial Evaluating Effectiveness And Complications

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: Ataturk Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 31 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the clinical results contributions to surgical success,and complications of mixed type of mesh materials as well as prolen mesh materials in sling surgery in a 3 year follow-up the first time in literature.

Detailed description

Broad based double forced sling operations were performed in 144 patients by using 3 different types of mesh materials between 2004 and 2007. Group I consisted of 48 patients in whom Vypromesh® (Ethicon,USA) was used; Group II consisted of 48 patients in whom Ultrapromesh®( Ethicon,USA) and Group III consisted of 48 patients in whom Prolene light mesh® (Johnson\&Johnson,USA) was used. The data of the patients and the success of the operation were evaluated based on 24hr pad test, ICIQ-SF scoring, and Korman questionnaire analysis. Main outcome measures:The Ultrapromesh® synthetic sling procedures have lower complications incidence and higher success rates than the other synthetic slings in 3-year follow-up.

Conditions

• Incontinence

Interventions

Type	Name	Description
PROCEDURE	Synthetic sling surgery	An incision of inverted A shape was inflicted on the anterior vaginal wall(AVW)of the vagina.The upper part of A shaped incision was formed into an island belonging to the vaginal wall.This patch was 3×4cm in most of the patients.Proximal AVWwas dissected as a flap.Synthetics mesh materials were first sutured onto the upper part of the A on the vaginal island with absorbable vicrly sutures.Then,with 2polypropilen sutures,these meshes were fixed on both the right and left sides of this island in a helical manner to form a suspension and using curved Kishner needles,the prolene sutures were transferred to suprapubic area.These sutures were ligated on the rectus fascia in a crosswise manner.The mobile lower wing was advanced onto the island and was sutured onto the vaginal skin with intermittent sutures using 3-0 monocryl sutures.After cystoscopy,the prolene sutures were ligated crosswise in the suprapubic region.Special attention was paid notto create much tension on the mesh material.

Timeline

• Start date: 2004-07-01
• Primary completion: 2007-07-01
• Completion: 2010-11-01
• First posted: 2011-05-05
• Last updated: 2011-05-05