Laparoscopic Sacropexy: Comparison of Mesh Attachment (MeshPlace)

This study is currently recruiting participants.
Verified June 2009 by Kantonsspital Aarau
Sponsor:
Information provided by:
Kantonsspital Aarau
ClinicalTrials.gov Identifier:
NCT00928239
First received: June 23, 2009
Last updated: June 24, 2009
Last verified: June 2009

June 23, 2009
June 24, 2009
June 2009
June 2011   (final data collection date for primary outcome measure)
Rate of Postoperative Constipation [ Time Frame: 6 to 8 weeks postoperatively ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00928239 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Laparoscopic Sacropexy: Comparison of Mesh Attachment
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Vaginal Vault Prolapse
  • 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 Name: laparoscopic sacrocolpopexy
  • 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 Name: laparoscopic sacrocolpopexy
  • 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.
    Intervention: Procedure: laparoscopic sacropexy with mid vaginal attachment
  • 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
    Intervention: Procedure: laparoscopic sacropexy with caudal vaginal attachment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
88
June 2014
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • rectocele
  • BMI>40
Female
18 Years and older
Yes
Not Provided
Switzerland
 
NCT00928239
KSA-MeshPlace
No
Dimitri Sarlos, Department of Gynecology and Obstetrics
Kantonsspital Aarau
Not Provided
Study Chair: Dimitri Sarlos, MD Kantonsspital Aarau, Department of Gynecology and Obstetrics
Kantonsspital Aarau
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP