Back to resultsAssisted Promontofixation Using Glue Versus Promontofixation Using Threads (PROCOL) (PROCOL)
Primary Purpose
Prolapse
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Laparostopic promontofixation using surgical glue
Laparostopic promontofixation using threads
Sponsored by
About this trial
This is an interventional health services research trial for Prolapse focused on measuring promontofixation, prolapse surgery
Eligibility Criteria
Inclusion Criteria:
- Age> 40 years
- Surgical indication of prolapse cure by promontofixation
- Valid social insurance
- French spoken and written
- Informed consent signed
- No exclusion criteria
Exclusion Criteria:
- Concomitant rectopexy
- Concomitant Hysterectomy
- Associated surgical procedure not compatible with measurement of operative time
- Refusal to participate in the study
- Pregnant or lactating woman (Article L 1121-5 of the french code of public health)
- Vulnerable persons (Article L 1121-6 of the french code of public health)
- Majors subject to legal protection or unable to express their consent (Article 1121-8 of the CSP)
- Participation in another protocol for less than 3 months
- Patient does not have all the inclusion criteria.
Sites / Locations
- Clinique Beau Soleil
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Promontofixation using glue
Promontofixation using threads
Arm Description
Patients in this arm will have a laparoscopic promontofixation using a biocompatible cyanoacrylate adhesive replacing some sutures to maintain the strips.
Patients in this arm will have a laparoscopic promontofixation using sutures with threads to maintain the strips.
Outcomes
Primary Outcome Measures
Operative time
The time elapsed between incision and closure
Secondary Outcome Measures
Collection of intra-operative complications
Collection of all the complications during the surgery (visceral wound, peroperative bleeding, other)
Collection of per-operative complications
Collection of the per-operative complications: pain at day 0 and day 1 (using the visual analog scale), urinary retention, postoperative haemorrhage or hematoma, fever> 38 ° 48 h after surgery, other complication
Collection of complications at 6 weeks
Pain by the Visuel Analog Scale, emergency consultation or generalist, rehospitalization / Reintervention, other complications
Tolerance of the prosthesis
Classification of the complications related to the insertion of protheses (from the International Urogynecological Association)
Tolerance of the prosthesis
Classification of the complications related to the insertion of protheses (from the International Urogynecological Association)
Tolerance of the prosthesis
Classification of the complications related to the insertion of protheses (from the International Urogynecological Association)
Objective anatomical results at 6 weeks
International Continence Society - Pelvic organe Prolapse - Quantification (POP Q scale): stage 0 (no prolapse is demonstrated) to stage 4 (vaginal eversion is essentially complete)
Objective anatomical results at 6 months
International Continence Society - Pelvic organe Prolapse - Quantification (POP Q scale): stage 0 (no prolapse is demonstrated) to stage 4 (vaginal eversion is essentially complete)
Objective anatomical results at 12 month
International Continence Society - Pelvic organe Prolapse - Quantification (POP Q scale): stage 0 (no prolapse is demonstrated) to stage 4 (vaginal eversion is essentially complete)
Quality of life: pelvic floor distress
The Pelvic Floor Distress Inventory-20 questionnary: it is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms.The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions
Quality of life: pelvic floor distress
The Pelvic Floor Distress Inventory-20 questionnary. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions
Quality of life: pelvic floor distress
The Pelvic Floor Distress Inventory-20 questionnary. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03624764
Brief Title
Assisted Promontofixation Using Glue Versus Promontofixation Using Threads (PROCOL)
Acronym
PROCOL
Official Title
A Randomized Comparative Study of Assisted Promontofixation Using Glue Versus Promontofixation Using Threads
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 2017 (Actual)
Primary Completion Date
October 4, 2019 (Actual)
Study Completion Date
January 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinique Beau Soleil
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The treatment of gynecological prolapse (organ removal) can be done by laparoscopy or vaginally. Laparoscopy is used in 1 out of 2 cases, but learning is difficult and operation time is long. One of the technical difficulties is related to the sutures to the threads. Some surgeons therefore use a glue to fix prosthetic reinforcements more easily and quickly, but this sizing technique has only been evaluated very little. Our study proposes to compare the technique of suture with the thread at the gluing of the prostheses in order to validate the merits of this new technique
Detailed Description
Laparoscopic promontofixation is a surgical technique considered by some as the reference technique. Its difficulty of learning and the duration of operation are factors limiting its diffusion. The use of cyanoacrylate glue is proposed to simplify the procedure, without there being any comparative studies between the sutures over and the sizing of prosthetic reinforcements.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolapse
Keywords
promontofixation, prolapse surgery
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Promontofixation using glue
Arm Type
Experimental
Arm Description
Patients in this arm will have a laparoscopic promontofixation using a biocompatible cyanoacrylate adhesive replacing some sutures to maintain the strips.
Arm Title
Promontofixation using threads
Arm Type
Active Comparator
Arm Description
Patients in this arm will have a laparoscopic promontofixation using sutures with threads to maintain the strips.
Intervention Type
Procedure
Intervention Name(s)
Laparostopic promontofixation using surgical glue
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Laparostopic promontofixation using threads
Intervention Description
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
Primary Outcome Measure Information:
Title
Operative time
Description
The time elapsed between incision and closure
Time Frame
one day
Secondary Outcome Measure Information:
Title
Collection of intra-operative complications
Description
Collection of all the complications during the surgery (visceral wound, peroperative bleeding, other)
Time Frame
one day
Title
Collection of per-operative complications
Description
Collection of the per-operative complications: pain at day 0 and day 1 (using the visual analog scale), urinary retention, postoperative haemorrhage or hematoma, fever> 38 ° 48 h after surgery, other complication
Time Frame
one day
Title
Collection of complications at 6 weeks
Description
Pain by the Visuel Analog Scale, emergency consultation or generalist, rehospitalization / Reintervention, other complications
Time Frame
6 weeks
Title
Tolerance of the prosthesis
Description
Classification of the complications related to the insertion of protheses (from the International Urogynecological Association)
Time Frame
6 weeks
Title
Tolerance of the prosthesis
Description
Classification of the complications related to the insertion of protheses (from the International Urogynecological Association)
Time Frame
6 months
Title
Tolerance of the prosthesis
Description
Classification of the complications related to the insertion of protheses (from the International Urogynecological Association)
Time Frame
12 months
Title
Objective anatomical results at 6 weeks
Description
International Continence Society - Pelvic organe Prolapse - Quantification (POP Q scale): stage 0 (no prolapse is demonstrated) to stage 4 (vaginal eversion is essentially complete)
Time Frame
Before surgery
Title
Objective anatomical results at 6 months
Description
International Continence Society - Pelvic organe Prolapse - Quantification (POP Q scale): stage 0 (no prolapse is demonstrated) to stage 4 (vaginal eversion is essentially complete)
Time Frame
6 months after surgery
Title
Objective anatomical results at 12 month
Description
International Continence Society - Pelvic organe Prolapse - Quantification (POP Q scale): stage 0 (no prolapse is demonstrated) to stage 4 (vaginal eversion is essentially complete)
Time Frame
12 months after surgery
Title
Quality of life: pelvic floor distress
Description
The Pelvic Floor Distress Inventory-20 questionnary: it is both a symptom inventory and a measure of the degree of bother and distress (quality-of-life) caused by pelvic floor symptoms.The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions
Time Frame
Before the surgery
Title
Quality of life: pelvic floor distress
Description
The Pelvic Floor Distress Inventory-20 questionnary. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions
Time Frame
6 months after the surgery
Title
Quality of life: pelvic floor distress
Description
The Pelvic Floor Distress Inventory-20 questionnary. The PFDI-20 includes 20 questions and 3 scales. Each of the 3 scales is scored from 0 (least distress) to 100 (greatest distress). The sum of the scores of these 3 scales serves as the overall summary score of the PFDI-20 and ranges from 0 - 300. The 3 scales include questions taken from the following widely used outcome measures: Urinary Distress Inventory - 6 questions, Pelvic Organ Prolapse Distress Inventory - 6 questions, and Colorectal-Anal Distress Inventory - 8 questions
Time Frame
12 months after the surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age> 40 years
Surgical indication of prolapse cure by promontofixation
Valid social insurance
French spoken and written
Informed consent signed
No exclusion criteria
Exclusion Criteria:
Concomitant rectopexy
Concomitant Hysterectomy
Associated surgical procedure not compatible with measurement of operative time
Refusal to participate in the study
Pregnant or lactating woman (Article L 1121-5 of the french code of public health)
Vulnerable persons (Article L 1121-6 of the french code of public health)
Majors subject to legal protection or unable to express their consent (Article 1121-8 of the CSP)
Participation in another protocol for less than 3 months
Patient does not have all the inclusion criteria.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe Courtieu
Organizational Affiliation
Clinqieu Beau Soleil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Beau Soleil
City
Montpellier
ZIP/Postal Code
34070
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Assisted Promontofixation Using Glue Versus Promontofixation Using Threads (PROCOL)
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