Abdominal Diastasis Repair by Robotic Surgery (PROMA1)

March 2, 2023 updated by: Assistance Publique - Hôpitaux de Paris

Robotic-assisted Diastasis of the Rectus Abdominis Muscles Repair: Evaluation of a Minimally Invasive Surgical Procedure

The objective of the study is to evaluate the feasibility of a robot-assisted minimally invasive surgical technique for the management of diastasis of the rectus abdominis. The effectiveness of this robotic surgery will be evaluated on the intermuscular distance measurement above and under umbilicus using ultrasound or CT-scan imaging.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a bi-centric, prospective, regional research.

Patients will be included in the:

  • Henri Mondor University Hospital in Créteil, in the plastic and reconstructive surgery department headed by Professor Meningaud.
  • Tenon University Hospital in Paris in the plastic and reconstructive surgery department of Dr. Atlan.

As part of this research, subjects will be identified as follows:

center number (3 numeric positions) - person selection order number in the center (4 numeric positions) - initial last name - initial first name This reference is unique and will be kept for the duration of the search.

A recruitment of 50 subjects is planned. (The investigator and/or monitor) will gradually complete a form, "Pre-included Patient Register", which will include all patients (initial and date of birth) who were approached to enter the study, whether finally included or not, as well as the reasons for not including them.

Patients meeting the following criteria cannot be included:

  • Patients participating or having participated in the last two months in another clinical study
  • Pregnant or breastfeeding patients
  • Patients not using contraception
  • Patients with umbilical hernia (hernia bag)
  • Patients with a history of abdominal surgery by median laparotomy
  • Patients with contraindications to general anesthesia
  • Any other reason that, in the investigator's opinion, could interfere with the proper conduct of the study

The trial includes: an inclusion visit, a surgical hospitalization and two follow-up visits

An initial inclusion visit,[VI], which allows you to:

  • check the inclusion and non-inclusion criteria explain and give consent to the patient's research participation (which will be retrieved the day before the intervention)
  • carry out the ultrasound or CT-scan for the diagnosis of diastasis.

Parameters collected during this visit

  • Physical examination
  • Patient's medical history relevant to the trial
  • Verification of compliance with inclusion and exclusion criteria
  • Ultrasound or CT-scan for the diagnosis of diastasis
  • Preoperative photographic plate

The surgical procedure is performed in a single step, under general anesthesia with the assistance of the Intuitiv SI robot. The patient is placed in supine position, with his arms along his body, in the Trendelenburg position with his legs down.

An antibioprophylaxis with Amoxicillin/clavulanic acid 1g/200mg IV is administered at induction.

Preoperative marking is performed to identify the palpated medial edges of the rectus abdominis, semilunar lines and costal awnings.

Three trocars are placed: a 12mm trocar, 2 to 3 fingertips above the pubis, median for the optics, a 8mm trocar in the right iliac fossa and a 8mm trocar in the left iliac fossa. Dissection is started with the finger or foam tip scissors through the opening of the median trocar to ensure that it is in the preaponeurotic plane, in front of the anterior sheath of the large rectus abdominis muscles.

The middle trocar is set up for the robot optics and insufflation of 13 mmHg CO2. The instrument trocars are then placed (8 or 5 mm depending on the robot : 8 mm for the Intuitiv Si robot). The preaponeurotic space is dissected in front of the anterior fascia of the rectus muscles to expose the white line to the umbilicus. The umbilicus is severed, it remains vascularized by the dermal network.

Then the dissection of the preaponeurotic space is continued to the xyphoid. Lateral dissection should not go more than 3cm beyond the semi lunar lines to maintain skin vascularization, limit dead spaces and seroma formation.

The anterior aponeuroses of the great rectus muscles are plicaturized by toothed wire (type QUILL PDO) from the suspubic region to the xyphoid. The umbilicus is attached to the fascia.

A redon or Blake drain 10 is placed through one of the 8mm holes. An abdominal compression dressing is applied at the end of the procedure.

Regarding surgical management and post-operative follow-up, the following parameters will be collect:

  • Duration of the intervention
  • Duration of hospitalization
  • Drainage time
  • Weight of skin resection in case of associated excess skin fat
  • Occurrence of post-operative complications: seromas, haematomas, infections, thromboembolic complications, scarring disorders

Follow-up visits will take place at 1,3 and 6 months after the intervention:

They will consist of:

  • an interrogation of the patient,

  • the performing of:

    • a clinical examination,
    • photographs of the face and profile of the scar
    • an abdominal ultrasound. Abdominal ultrasound was used to measure the intermuscular distance at three points (xyphoid, 3 cm above and below the umbilicus, 2 cm below the umbilicus). The average intermuscular distance was calculated from these three measurements
    • a qualitative evaluation of the scar using the VAS and POSAS scale (secondary criteria)
    • a patient satisfaction assessment using VAS scale.

The main efficacy criterion is the average intermuscular distance at 3 months post-operatively obtained by averaging ultrasound measurements at the three abdominal points defined by Beer.

The secondary efficacy criteria are:

  • Duration of the procedure, duration of hospitalization, duration of post-operative drainage
  • Occurrence of post-operative complications (seroma or hematoma collection, thromboembolic accident, infection, scarring disorders)
  • Evaluation of the scar quality evaluated by the POSAS scale
  • Overall patient satisfaction with the intervention and outcome (VAS 0 to 10)

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jean-Paul MENINGEAUD, PhD
  • Phone Number: +33 1 49 81 45 33
  • Email: meningaud@me.com

Study Locations

  • France
    • Val De Marne
      • Créteil, Val De Marne, France, 94000
        • Recruiting
        • Hôpital Henri Mondor
        • Contact:
          • Barbara Hersant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient 18 years old or older with an indication for diastasis

Description

Inclusion Criteria:

  • Patient 18 years old or older with an indication for diastasis
  • Patient who has given his or her non-opposition to participation in the research
  • Patient able to understand the requirements of the trial

Exclusion Criteria:

  • Patients participating or having participated in the last two months in another clinical study
  • Pregnant or breastfeeding patients
  • Patients not using contraception
  • Patients with umbilical hernia (hernia bag)
  • Patients with a history of abdominal surgery by median laparotomy
  • Patients with contraindications to general anesthesia
  • Any other reason that, in the investigator's opinion, could interfere with the proper conduct of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diastasis of the rectus abdominis muscles
Diastasis of the rectus abdominis muscles repair using the Intuitiv SI robot
Procedure: Robotic-assisted diastasis of the rectus abdominis muscles repair
Diastasis of the rectus abdominis muscles repair using the Intuitiv SI robot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average intermuscular distance
Time Frame: At 3 months post surgery
Average intermuscular distance post-operatively obtained by averaging ultrasound measurements at the three abdominal points defined by Beer.
At 3 months post surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgery
Time Frame: During the surgery
Duration of the procedure
During the surgery
Hospitalization
Time Frame: Up to 4 days
Duration of hospitalization
Up to 4 days
Drainage
Time Frame: Up to 2 days
Duration of post-operative drainage
Up to 2 days
Complications at 1 month
Time Frame: At 1 month
Occurrence of post-operative complications at 1 month
At 1 month
Complications at 3 months
Time Frame: At 3 months
Occurrence of post-operative complications at 3 months
At 3 months
Complications at 6 months
Time Frame: At 6 months
Occurrence of post-operative complications at 6 months
At 6 months
Scar quality at 1 month post surgery
Time Frame: at 1 months
Evaluation of the scar quality by the POSAS scale
at 1 months
Scar quality at 3 months post surgery
Time Frame: at 3 months
Evaluation of the scar quality by the POSAS scale
at 3 months
Scar quality at 6 months post surgery
Time Frame: at 6 months
Evaluation of the scar quality by the POSAS scale
at 6 months
Patient satisfaction at 1 month post surgery
Time Frame: At 1 month
Overall patient satisfaction with the intervention and outcome
At 1 month
Patient satisfaction at 3 months post surgery
Time Frame: At 3 months
Overall patient satisfaction with the intervention and outcome
At 3 months
Patient satisfaction at 6 months post surgery
Time Frame: At 6 months
Overall patient satisfaction with the intervention and outcome
At 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Barbara HERSANT, APHP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2020

Primary Completion (Actual)

October 2, 2022

Study Completion (Anticipated)

September 25, 2023

Study Registration Dates

First Submitted

October 3, 2019

First Submitted That Met QC Criteria

November 22, 2019

First Posted (Actual)

November 25, 2019

Study Record Updates

Last Update Posted (Actual)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 2, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP190484

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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