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Completed

NCT Number: NCT03624764

Assisted Promontofixation Using Glue Versus Promontofixation Using Threads (PROCOL)

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

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Key information

Conditions

Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Clinique Beau Soleil

Montpellier, 34070, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparostopic promontofixation using surgical glue

Procedure

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

Procedure

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 outcomes

  1. Operative time

    Time frame: one day

    The time elapsed between incision and closure

Secondary outcomes

  1. Collection of intra-operative complications

    Time frame: one day

    Collection of all the complications during the surgery (visceral wound, peroperative bleeding, other)

  2. Collection of per-operative complications

    Time frame: one day

    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

  3. Collection of complications at 6 weeks

    Time frame: 6 weeks

    Pain by the Visuel Analog Scale, emergency consultation or generalist, rehospitalization / Reintervention, other complications

  4. Tolerance of the prosthesis

    Time frame: 6 weeks

    Classification of the complications related to the insertion of protheses (from the International Urogynecological Association)

  5. Tolerance of the prosthesis

    Time frame: 6 months

    Classification of the complications related to the insertion of protheses (from the International Urogynecological Association)

  6. Tolerance of the prosthesis

    Time frame: 12 months

    Classification of the complications related to the insertion of protheses (from the International Urogynecological Association)

  7. Objective anatomical results at 6 weeks

    Time frame: Before surgery

    International Continence Society - Pelvic organe Prolapse - Quantification (POP Q scale): stage 0 (no prolapse is demonstrated) to stage 4 (vaginal eversion is essentially complete)

  8. Objective anatomical results at 6 months

    Time frame: 6 months after surgery

    International Continence Society - Pelvic organe Prolapse - Quantification (POP Q scale): stage 0 (no prolapse is demonstrated) to stage 4 (vaginal eversion is essentially complete)

  9. Objective anatomical results at 12 month

    Time frame: 12 months after surgery

    International Continence Society - Pelvic organe Prolapse - Quantification (POP Q scale): stage 0 (no prolapse is demonstrated) to stage 4 (vaginal eversion is essentially complete)

  10. Quality of life: pelvic floor distress

    Time frame: Before the surgery

    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

  11. Quality of life: pelvic floor distress

    Time frame: 6 months after the surgery

    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

  12. Quality of life: pelvic floor distress

    Time frame: 12 months after the surgery

    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

Sponsors and collaborators

Lead sponsor

Clinique Beau Soleil

Other

Registry information

Official study title

A Randomized Comparative Study of Assisted Promontofixation Using Glue Versus Promontofixation Using Threads

Acronym: PROCOL

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Aug 10, 2018
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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