Pelvic Organ ProlapseSUSPENSIONNCT03582852
Laparoscopic Sacrocolpexy Versus Lateral Suspension
A study testing Surgical treatment of genital prolapse in people with Pelvic Organ Prolapse, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Surgical treatment of genital prolapse can be performed by laparoscopic surgery or by vaginal surgery, with or without using meshes. Laparoscopic sacrocolpopexy, which consist in fixing a mesh between vaginal anterior wall and the promontory is the gold standard procedure to treat anterior prolapse or of the vaginal… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Surgical treatment of genital prolapse
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2018to 20 Apr 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at least 18 years old.
- Patients who agreed to participate in the study and signed informed consent.
- Patient affiliated to a social protection system.
- Surgical indication by laparoscopy of prolapse cure symptomatic of the anterior stage and / or isolated medium.
Who cannot join
- Minor patient.
- Patient refusing to sign the consent or unable to receive the necessary information to give informed consent.
- Patient not affiliated to a social protection system.
- Presence of one or more contraindication (s) to laparoscopy
- Presence of posterior prolapse requiring surgical treatment
- Need for an associated surgical procedure.
- Major people under legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Sacrocolpexy Versus Lateral Suspension With a Mesh for the Treatment of Pelvic Organ Prolapse : a Randomized Controlled Trial
Surgical treatment of genital prolapse can be performed by laparoscopic surgery or by vaginal surgery, with or without using meshes. Laparoscopic sacrocolpopexy, which consist in fixing a mesh between vaginal anterior wall and the promontory is the gold standard procedure to treat anterior prolapse or of the vaginal vault. Most of studies shows a success rate of 80% of this procedure.
However, access to the promontory could be difficult in patients because of adherences or anatomical reasons. This step of the procedure also exposes to risk of ureteral or vascular injuries. Recent issues have also found spondylodiscitis cases.
Read more
The technique of laparoscopic lateral suspension with mesh was developed by Dubuisson in 1998 allows not to have to approach the promontory and avoids both the risk of vascular injury and ureteral damage of laparoscopic sacrocolpopexy. Instead of attach the mesh to the promontory, the procedure consists in spreading out bilaterally, a subperitoneal T-shaped mesh in the anterior abdominal wall. The aim of this study is to compare the clinical and functional efficiency of the lateral suspension versus laparoscopic sacrocolpopexy.
It is a prospective, randomized, monocentric study compared two groups The study hypothesis is that the lateral suspension would provide correction than the laparoscopic sacrocolpopexy.
The primary outcome is the comparison of anatomic correction rates at 1 year Success is defined as 1 year Ba et C points < -1 centimeter in POP-Q international score.
Secondary endpoints are improve of quality of life evaluated with the validated P-QOL questionnaire, and complications rates, including post-operative posterior prolapse.
Number of subjects required is 72 patients, 36 in each group having a laparoscopic sacrocolpopexy or lateral suspension.
Outcomes will be evaluated at 1 month and 1 year post-operative consultation
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Surgical treatment of genital prolapse
- 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.
Surgical treatment of genital prolapseProcedure or surgery
Laparoscopy performed according to the usual technique of the participating center with pneumoperitoneum between 12 and 15 mmHg. Placement of the 5 mm trocar operator left and right iliac fossa and 5 mm pubic addition.
| Study group | Role | What they receive |
|---|---|---|
| promontory | Active comparator | Laparoscopic sacrocolpopexy, which consist in fixing a mesh between vaginal anterior wall Receives: Procedure: Surgical treatment of genital prolapse |
| laparoscopic lateral suspension | Active comparator | The procedure consists in spreading out bilaterally, a subperitoneal T-shaped mesh in the anterior abdominal wall Receives: Procedure: Surgical treatment of genital prolapse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate cervico-urethral hypermobility
Success is defined by two points inferior at 1 centimeter in Pelvic organs prolapse quantification (POP-Q) international score. defining a symptomatic or asymptomatic state
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start11 Apr 2018
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Olivier ARNAUD, Director, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582852
- Sponsor's protocol ID
- 2017-43
- Other IDs
- 2017-A02650-53
- Acronym
- SUSPENSION
- Status last verified
- Aug 2022
- First submitted
- 22 May 2018
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Sacrocolpexy Versus Lateral Suspension With a Mesh for the Treatment of Pelvic Organ Prolapse : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03582852
- Acronym / sponsor ID
- SUSPENSION / 2017-43
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 11 Jul 2018 (actual)
- 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.
Surgical treatment of genital prolapse can be performed by laparoscopic surgery or by vaginal surgery, with or without using meshes. Laparoscopic sacrocolpopexy, which consist in fixing a mesh between vaginal anterior wall and the promontory is the gold standard procedure to treat anterior prolapse or of the vaginal vault. Most of studies shows a success rate of 80% of this procedure.
However, access to the promontory could be difficult in patients because of adherences or anatomical reasons. This step of the procedure also exposes to risk of ureteral or vascular injuries. Recent issues have also found spondylodiscitis cases.
The technique of laparoscopic lateral suspension with mesh was developed by Dubuisson in 1998 allows not to have to approach the promontory and avoids both the risk of vascular injury and ureteral damage of laparoscopic sacrocolpopexy. Instead of attach the mesh to the promontory, the procedure consists in spreading out bilaterally, a subperitoneal T-shaped mesh in the anterior abdominal wall. The aim of this study is to compare the clinical and functional efficiency of the lateral suspension versus laparoscopic sacrocolpopexy.
It is a prospective, randomized, monocentric study compared two groups The study hypothesis is that the lateral suspension would provide correction than the laparoscopic sacrocolpopexy.
The primary outcome is the comparison of anatomic correction rates at 1 year Success is defined as 1 year Ba et C points < -1 centimeter in POP-Q international score.
Secondary endpoints are improve of quality of life evaluated with the validated P-QOL questionnaire, and complications rates, including post-operative posterior prolapse.
Number of subjects required is 72 patients, 36 in each group having a laparoscopic sacrocolpopexy or lateral suspension.
Outcomes will be evaluated at 1 month and 1 year post-operative consultation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| promontory | Active comparator | Procedure: Surgical treatment of genital prolapseLaparoscopic sacrocolpopexy, which consist in fixing a mesh between vaginal anterior wall |
| laparoscopic lateral suspension | Active comparator | Procedure: Surgical treatment of genital prolapseThe procedure consists in spreading out bilaterally, a subperitoneal T-shaped mesh in the anterior abdominal wall |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients at least 18 years old.
- Patients who agreed to participate in the study and signed informed consent.
- Patient affiliated to a social protection system.
- Surgical indication by laparoscopy of prolapse cure symptomatic of the anterior stage and / or isolated medium.
Key exclusion criteria (7 listed)
- Minor patient.
- Patient refusing to sign the consent or unable to receive the necessary information to give informed consent.
- Patient not affiliated to a social protection system.
- Presence of one or more contraindication (s) to laparoscopy
- Presence of posterior prolapse requiring surgical treatment
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 |
|---|---|---|
| Surgical treatment of genital prolapseLaparoscopy performed according to the usual technique of the participating center with pneumoperitoneum between 12 and 15 mmHg. Placement of the 5 mm trocar operator left and right iliac fossa and 5 mm pubic addition. | Procedure or surgery | laparoscopic lateral suspension, promontory |
Primary outcome
Evaluate cervico-urethral hypermobility
Time frame: one year
Success is defined by two points inferior at 1 centimeter in Pelvic organs prolapse quantification (POP-Q) international score. defining a symptomatic or asymptomatic state
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
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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.
Jean-Olivier ARNAUD, Director study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical treatment of genital prolapse in people with Pelvic Organ Prolapse, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 9 Aug 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate cervico-urethral hypermobility (time frame: one year). 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 9 Aug 2022.