Vaginal Vault ProlapseMeshPlaceNCT00928239
Laparoscopic Sacropexy: Comparison of Mesh Attachment
A study testing laparoscopic sacropexy with mid vaginal attachment and laparoscopic sacropexy with caudal vaginal attachment in people with Vaginal Vault Prolapse, run by Kantonsspital Aarau at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginal Vault Prolapse
- What is being tested?
- laparoscopic sacropexy with mid vaginal attachment and laparoscopic sacropexy with caudal vaginal attachment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2009to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- vaginal vault prolapse
- recurrence of vaginal vault prolapse
- signed consent
Who cannot join
- rectocele
- BMI>40
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Aarau
Aarau, Canton of Aargau, 5001
LaVonne A Kots, MD, +41 62 8385027, lavonne.kots@ksa.ch
Dimitri Sarlos, MD
About this study
Official title: Laparoscopic Sacropexy: Randomized Clinical Trial to Compare Two Different Attachment Sites of the Dorsal Mesh at the Vaginal Insertion(MeshPlace)
The purpose of this study is to compare postoperative complications and outcome two different attachment sites of the dorsal mesh support in laparoscopic sacropexy.
Read the 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
- Being tested
- laparoscopic sacropexy with mid vaginal attachment, laparoscopic sacropexy with caudal vaginal attachment
- Keywords
- vaginal vault prolapse, laparoscopic sacropexy
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic sacropexy with mid vaginal attachmentProcedure or surgery
Also called laparoscopic sacrocolpopexy
- 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 attachmentProcedure or surgery
Also called laparoscopic sacrocolpopexy
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: laparoscopic sacropexy with caudal vaginal attachment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Postoperative Constipation
Measured: 6 to 8 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2011 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal Vault ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Aarau
- Sponsor type
- University, hospital or other
- Investigators
- Dimitri Sarlos, MD, Study chair, Kantonsspital Aarau, Department of Gynecology and Obstetrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928239
- Sponsor's protocol ID
- KSA-MeshPlace
- Acronym
- MeshPlace
- Status last verified
- Jun 2009
- First submitted
- 23 Jun 2009
- Last updated
- 25 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Sacropexy: Randomized Clinical Trial to Compare Two Different Attachment Sites of the Dorsal Mesh at the Vaginal Insertion(MeshPlace)
- ClinicalTrials.gov ID
- NCT00928239
- Acronym / sponsor ID
- MeshPlace / KSA-MeshPlace
- Conditions
- Vaginal Vault Prolapse
- Keywords
- vaginal vault prolapse, laparoscopic sacropexy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Kantonsspital AarauUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2011 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: laparoscopic sacropexy with mid vaginal attachmentArm1: 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. |
| 2 | Active comparator | Procedure: laparoscopic sacropexy with caudal vaginal attachmentArm 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- vaginal vault prolapse
- recurrence of vaginal vault prolapse
- signed consent
Key exclusion criteria (2 listed)
- rectocele
- BMI>40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic sacropexy with mid vaginal attachmentAlso: laparoscopic sacrocolpopexy* 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 | Procedure or surgery | 1 |
| laparoscopic sacropexy with caudal vaginal attachmentAlso: laparoscopic sacrocolpopexy* 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 | Procedure or surgery | 2 |
Primary outcome
Rate of Postoperative Constipation
Time frame: 6 to 8 weeks postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitri Sarlos, MD study chair
Kantonsspital Aarau, Department of Gynecology and Obstetrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic sacropexy with mid vaginal attachment and laparoscopic sacropexy with caudal vaginal attachment in people with Vaginal Vault Prolapse, run by Kantonsspital Aarau at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Postoperative Constipation (time frame: 6 to 8 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2009.