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Laparoscopic Sacropexy: Comparison of Mesh Attachment (MeshPlace)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Kantonsspital Aarau.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kantonsspital Aarau
ClinicalTrials.gov Identifier:
NCT00928239
First received: June 23, 2009
Last updated: June 24, 2009
Last verified: June 2009
  Purpose

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


Condition Intervention
Vaginal Vault Prolapse
Procedure: laparoscopic sacropexy with mid vaginal attachment
Procedure: laparoscopic sacropexy with caudal vaginal attachment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Laparoscopic Sacropexy: Randomized Clinical Trial to Compare Two Different Attachment Sites of the Dorsal Mesh at the Vaginal Insertion(MeshPlace)

Further study details as provided by Kantonsspital Aarau:

Primary Outcome Measures:
  • Rate of Postoperative Constipation [ Time Frame: 6 to 8 weeks postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 88
Study Start Date: June 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: laparoscopic sacrocolpopexy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • rectocele
  • BMI>40
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928239

Locations
Switzerland
Kantonsspital Aarau Recruiting
Aarau, Aargau, Switzerland, 5001
Contact: LaVonne A Kots, MD    +41 62 8385027    lavonne.kots@ksa.ch   
Principal Investigator: Dimitri Sarlos, MD         
Sub-Investigator: LaVonne A Kots, MD         
Sponsors and Collaborators
Kantonsspital Aarau
Investigators
Study Chair: Dimitri Sarlos, MD Kantonsspital Aarau, Department of Gynecology and Obstetrics
  More Information

No publications provided

Responsible Party: Dimitri Sarlos, Department of Gynecology and Obstetrics
ClinicalTrials.gov Identifier: NCT00928239     History of Changes
Other Study ID Numbers: KSA-MeshPlace
Study First Received: June 23, 2009
Last Updated: June 24, 2009
Health Authority: Switzerland: Ethikkommission

Keywords provided by Kantonsspital Aarau:
vaginal vault prolapse
laparoscopic sacropexy

Additional relevant MeSH terms:
Pelvic Organ Prolapse
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 20, 2014