Laparoscopic Sacropexy: Comparison of Mesh Attachment (MeshPlace)

Laparoscopic Sacropexy: Randomized Clinical Trial to Compare Two Different Attachment Sites of the Dorsal Mesh at the Vaginal Insertion(MeshPlace)

The purpose of this study is to compare postoperative complications and outcome two different attachment sites of the dorsal mesh support in laparoscopic sacropexy.

Study Overview

• Status: Unknown
• Conditions: Vaginal Vault Prolapse
• Intervention / Treatment: Procedure: laparoscopic sacropexy with mid vaginal attachment; Procedure: laparoscopic sacropexy with caudal vaginal attachment

Detailed Description

Laparoscopic sacropexy has become a well established treatment option for vaginal vault prolapse with excellent outcome and low rates of recurrence. Compared to the similar vaginal sacropexy procedure a significant rate of postoperative constipation is reported. As the surgical technique is very similar for both procedures it could be possible that the exposure of the lower vaginal wall and placement and of the dorsal mesh and closer proximity to the colon in laparoscopic sacropexy might cause this. In this randomized controlled clinical trial we compare two different attachment sites for the dorsal mesh during laparoscopic sacropexy. One group is randomized for attachment in the middle of the dorsal wall of the vaginal stump and for the other group preparation and attachment for the dorsal mesh is performed deeper in the lower pelvis for an attachment at the distal part of the dorsal vaginal wall.

Peri-operative data, intra- and postoperative complications and results of short-term (constipation) and long-term( recurrences rate) outcome are recorded.

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Aargau
    • Aarau, Aargau, Switzerland, 5001
      • Recruiting
      • Kantonsspital Aarau
      • Contact: LaVonne A Kots, MD; Phone Number: +41 62 8385027; Email: lavonne.kots@ksa.ch
      • Principal Investigator: Dimitri Sarlos, MD
      • Sub-Investigator: LaVonne A Kots, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• vaginal vault prolapse
• recurrence of vaginal vault prolapse
• signed consent

Exclusion Criteria:

• rectocele
• BMI>40

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Arm1: Laparoscopic repair of vaginal vault prolapse. Laparoscopic sacropexy procedure as described in previous publication(Sarlos D, Brandner S, Kots L, Gygax N, Schaer G. Laparoscopic sacrocolpopexy for uterine and post-hysterectomy prolapse: anatomical results, quality of life and perioperative outcome-a prospective study with 101 cases. Int Urogynecol JPelvic Floor Dysfunct. 2008 Oct;19(10):1415-22. Epub 2008 Jun 7. PubMed PMID: 18536861) with attachment to the caudal part of the vagina and the apex.	Procedure: laparoscopic sacropexy with mid vaginal attachment; supracervical hysterectomy for uterine prolapse; exposure of the anterior longitudinal ligament of sacrum and recto-vaginal septum posterior; dissection up to ventrolateral part of the levator ani muscle; Anterior dissection of vesico-vaginal fascia up to the lower third of the vagina below the trigonum of bladder; Two separate meshes, Gynemesh® (Johnson&Johnson) a polypropylene mesh, for anterior and posterior compartment; suturing of posterior mesh caudally to levator ani muscle and proximally 4cm from the apex of the vagina or cervical stump; placement of anterior mesh underneath bladder and attachment to caudal part of the vagina and the apex; suturing together anterior and posterior mesh are sutured together at level of vaginal apex and attachment to longitudinal sacral ligament at level of S2; Other Names: laparoscopic sacrocolpopexy
Active Comparator: 2; Arm 2: Laparoscopic repair of vaginal vault prolapse. Laparoscopic sacropexy procedure as described in previous publication(Sarlos D, Brandner S, Kots L, Gygax N, Schaer G. Laparoscopic sacrocolpopexy for uterine and post-hysterectomy prolapse: anatomical results, quality of life and perioperative outcome-a prospective study with 101 cases. Int Urogynecol JPelvic Floor Dysfunct. 2008 Oct;19(10):1415-22. Epub 2008 Jun 7. PubMed PMID: 18536861) with attachment of the dorsal mesh at distal end of vagina at dorsal vaginal wall	Procedure: laparoscopic sacropexy with caudal vaginal attachment; supracervical hysterectomy for uterine prolapse; exposure of the anterior longitudinal ligament of sacrum and recto-vaginal septum posterior; dissection up to ventrolateral part of the levator ani muscle; Anterior dissection of vesico-vaginal fascia up to the lower third of the vagina below the trigonum of bladder; Two separate meshes, Gynemesh® (Johnson&Johnson) a polypropylene mesh, for anterior and posterior compartment; suturing of posterior mesh caudally to the levator ani muscle and proximally at caudal part of the vagina or cervical stump; placement of anterior mesh underneath bladder and attachment to caudal part of the vagina and the apex; suturing together anterior and posterior mesh are sutured together at level of vaginal apex and attachment to longitudinal sacral ligament at level of S2; Other Names: laparoscopic sacrocolpopexy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of Postoperative Constipation	6 to 8 weeks postoperatively

Collaborators and Investigators

• Sponsor: Kantonsspital Aarau
• Investigators: Study Chair: Dimitri Sarlos, MD, Kantonsspital Aarau, Department of Gynecology and Obstetrics

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Anticipated): June 1, 2011
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: June 23, 2009
• First Submitted That Met QC Criteria: June 24, 2009
• First Posted (Estimate): June 25, 2009

Study Record Updates

• Last Update Posted (Estimate): June 25, 2009
• Last Update Submitted That Met QC Criteria: June 24, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: vaginal vault prolapse; laparoscopic sacropexy
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: KSA-MeshPlace

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No