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Laparoscopic Sacropexy: Comparison of Mesh Attachment (MeshPlace)

Primary Purpose

Vaginal Vault Prolapse

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
laparoscopic sacropexy with mid vaginal attachment
laparoscopic sacropexy with caudal vaginal attachment
Sponsored by
Kantonsspital Aarau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Vault Prolapse focused on measuring vaginal vault prolapse, laparoscopic sacropexy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • rectocele
  • BMI>40

Sites / Locations

  • Kantonsspital AarauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Rate of Postoperative Constipation

Secondary Outcome Measures

Full Information

First Posted
June 23, 2009
Last Updated
June 24, 2009
Sponsor
Kantonsspital Aarau
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1. Study Identification

Unique Protocol Identification Number
NCT00928239
Brief Title
Laparoscopic Sacropexy: Comparison of Mesh Attachment
Acronym
MeshPlace
Official Title
Laparoscopic Sacropexy: Randomized Clinical Trial to Compare Two Different Attachment Sites of the Dorsal Mesh at the Vaginal Insertion(MeshPlace)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kantonsspital Aarau

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Vault Prolapse
Keywords
vaginal vault prolapse, laparoscopic sacropexy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
laparoscopic sacropexy with mid vaginal attachment
Other Intervention Name(s)
laparoscopic sacrocolpopexy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
laparoscopic sacropexy with caudal vaginal attachment
Other Intervention Name(s)
laparoscopic sacrocolpopexy
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of Postoperative Constipation
Time Frame
6 to 8 weeks postoperatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: vaginal vault prolapse recurrence of vaginal vault prolapse signed consent Exclusion Criteria: rectocele BMI>40
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitri Sarlos, MD
Organizational Affiliation
Kantonsspital Aarau, Department of Gynecology and Obstetrics
Official's Role
Study Chair
Facility Information:
Facility Name
Kantonsspital Aarau
City
Aarau
State/Province
Aargau
ZIP/Postal Code
5001
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LaVonne A Kots, MD
Phone
+41 62 8385027
Email
lavonne.kots@ksa.ch
First Name & Middle Initial & Last Name & Degree
Dimitri Sarlos, MD
First Name & Middle Initial & Last Name & Degree
LaVonne A Kots, MD

12. IPD Sharing Statement

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Laparoscopic Sacropexy: Comparison of Mesh Attachment

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