MeshPlace: Laparoscopic Sacropexy: Comparison of Mesh Attachment

Sponsor

Kantonsspital Aarau (Other)

Overall Status

Unknown status

CT.gov ID

NCT00928239

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Vault Prolapse	Procedure: laparoscopic sacropexy with mid vaginal attachment Procedure: laparoscopic sacropexy with caudal vaginal attachment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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)

Study Start Date :

Jun 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2011

Anticipated Study Completion Date :

Jun 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Rate of Postoperative Constipation [6 to 8 weeks postoperatively]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

vaginal vault prolapse
recurrence of vaginal vault prolapse
signed consent

Exclusion Criteria:

rectocele
BMI>40

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kantonsspital Aarau	Aarau	Aargau	Switzerland	5001

Sponsors and Collaborators

Kantonsspital Aarau

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00928239

Other Study ID Numbers:

KSA-MeshPlace

First Posted:

Jun 25, 2009

Last Update Posted:

Jun 25, 2009

Last Verified:

Jun 1, 2009

Keywords provided by , ,

vaginal vault prolapse

laparoscopic sacropexy

Additional relevant MeSH terms:

Prolapse

Pelvic Organ Prolapse

Study Results

No Results Posted as of Jun 25, 2009