Assisted Promontofixation Using Glue Versus Promontofixation Using Threads (PROCOL)
NCT ID: NCT03624764
Last Updated: 2021-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2017-01-04
2020-01-04
Brief Summary
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Detailed Description
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The main objective of the study is to compare the operative time of promontofixation by coelioscopy with suture using threads to promontofixation using glue.
Secondary objectives are the comparison between the two groups of complications per and postoperative, objective anatomical results and functional results of the tissue reaction judged by clinical examination (palpation) and ultrasound and direct cost.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Promontofixation using glue
Patients in this arm will have a laparoscopic promontofixation using a biocompatible cyanoacrylate adhesive replacing some sutures to maintain the strips.
Laparostopic promontofixation using surgical glue
The technique involves implanting a prosthetic tissue (tape) between the bladder and the vagina, suspending the cervix or the vagina affectionately, associated or not with a posterior strip placed between the rectum and the vagina fixed on the small pelvis muscles. Each strip is held by the surgical glue (cyanoacrylate biocompatible adhesive)
Promontofixation using threads
Patients in this arm will have a laparoscopic promontofixation using sutures with threads to maintain the strips.
Laparostopic promontofixation using threads
The technique involves implanting a prosthetic tissue (tape) between the bladder and the vagina, suspending the cervix or the vagina affectionately, associated or not with a posterior strip placed between the rectum and the vagina fixed on the small pelvis muscles. Each strip is held by sutures with threads
Interventions
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Laparostopic promontofixation using surgical glue
The technique involves implanting a prosthetic tissue (tape) between the bladder and the vagina, suspending the cervix or the vagina affectionately, associated or not with a posterior strip placed between the rectum and the vagina fixed on the small pelvis muscles. Each strip is held by the surgical glue (cyanoacrylate biocompatible adhesive)
Laparostopic promontofixation using threads
The technique involves implanting a prosthetic tissue (tape) between the bladder and the vagina, suspending the cervix or the vagina affectionately, associated or not with a posterior strip placed between the rectum and the vagina fixed on the small pelvis muscles. Each strip is held by sutures with threads
Eligibility Criteria
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Inclusion Criteria
2. Surgical indication of prolapse cure by promontofixation
3. Valid social insurance
4. French spoken and written
5. Informed consent signed
Exclusion Criteria
2. Concomitant Hysterectomy
3. Associated surgical procedure not compatible with measurement of operative time
4. Refusal to participate in the study
5. Pregnant or lactating woman (Article L 1121-5 of the french code of public health)
6. Vulnerable persons (Article L 1121-6 of the french code of public health)
7. Majors subject to legal protection or unable to express their consent (Article 1121-8 of the CSP)
8. Participation in another protocol for less than 3 months
40 Years
FEMALE
No
Sponsors
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Clinique Beau Soleil
OTHER
Responsible Party
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Principal Investigators
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Christophe Courtieu
Role: PRINCIPAL_INVESTIGATOR
Clinqieu Beau Soleil
Locations
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Clinique Beau Soleil
Montpellier, , France
Countries
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Other Identifiers
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2016- A01387-44
Identifier Type: -
Identifier Source: org_study_id
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