NCT00928239

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 25, 2009

Status Verified

June 1, 2009

Enrollment Period

2 years

First QC Date

June 23, 2009

Last Update Submit

June 24, 2009

Conditions

Vaginal Vault Prolapse

Keywords

vaginal vault prolapselaparoscopic sacropexy

Outcome Measures

Primary Outcomes (1)

  • Rate of Postoperative Constipation

    6 to 8 weeks postoperatively

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Interventions

laparoscopic sacropexy with mid vaginal attachmentPROCEDURE

* 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

Also known as: laparoscopic sacrocolpopexy
1
laparoscopic sacropexy with caudal vaginal attachmentPROCEDURE

* 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

Also known as: laparoscopic sacrocolpopexy
2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • rectocele
  • BMI\>40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Dimitri Sarlos, MD

    Kantonsspital Aarau, Department of Gynecology and Obstetrics

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 25, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2014

Last Updated

June 25, 2009

Record last verified: 2009-06

Locations

CH(1)