Laparoscopic Sacropexy: Comparison of Mesh Attachment

NCT ID: NCT00928239

Last Updated: 2009-06-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2014-06-30

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.

Conditions

Vaginal Vault Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

laparoscopic sacropexy with mid vaginal attachment

Intervention Type: PROCEDURE

• 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

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

Group Type: ACTIVE_COMPARATOR

laparoscopic sacropexy with caudal vaginal attachment

Intervention Type: PROCEDURE

• 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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

laparoscopic sacrocolpopexy; laparoscopic sacrocolpopexy

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• rectocele
• BMI>40

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Kantonsspital Aarau

OTHER

Sponsor Role: lead

Responsible Party

Department of Gynecology and Obstetrics

Principal Investigators

Dimitri Sarlos, MD

Role: STUDY_CHAIR

Kantonsspital Aarau, Department of Gynecology and Obstetrics

Locations

Kantonsspital Aarau

Aarau, Canton of Aargau, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Facility Contacts

LaVonne A Kots, MD

Role: primary

lavonne.kots@ksa.ch

+41 62 8385027

Other Identifiers

KSA-MeshPlace

Identifier Type: -

Identifier Source: org_study_id