Laparoscopic Sacropexy: Comparison of Mesh Attachment

Vaginal Vault Prolapse Clinical Trial

— MeshPlace  

Official title:

Laparoscopic Sacropexy: Randomized Clinical Trial to Compare Two Different Attachment Sites of the Dorsal Mesh at the Vaginal Insertion(MeshPlace)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00928239
• Other study ID #: KSA-MeshPlace
• Status: Recruiting
• Phase: N/A
• First received: June 23, 2009
• Last updated: June 24, 2009
• Start date: June 2009
• Est. completion date: June 2014

Study information

• Verified date: June 2009
• Source: Kantonsspital Aarau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: June 2014
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• vaginal vault prolapse

• recurrence of vaginal vault prolapse

• signed consent

Exclusion Criteria:

• rectocele

• BMI>40

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse
• Vaginal Vault Prolapse

Intervention

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
• 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

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau	Aargau

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Aarau

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Postoperative Constipation		6 to 8 weeks postoperatively	No