Clinical trial NCT04176874: Abdominal Diastasis Repair by Robotic Surgery
Official title: Robotic-assisted Diastasis of the Rectus Abdominis Muscles Repair: Evaluation of a Minimally Invasive Surgical Procedure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diastasis of Muscle, Other Site
Keywords: Diastasis recti
Rectus abdominis diastasis
Robotic surgical procedure
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient 18 years old or older with an indication for diastasis

Brief summary: 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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Average intermuscular distance
timeFrame: At 3 months post surgery
Secondary outcomes:
measure: Surgery
timeFrame: During the surgery
measure: Hospitalization
timeFrame: Up to 4 days
measure: Drainage
timeFrame: Up to 2 days
measure: Complications at 1 month
timeFrame: At 1 month
measure: Complications at 3 months
timeFrame: At 3 months
measure: Complications at 6 months
timeFrame: At 6 months
measure: Scar quality at 1 month post surgery
timeFrame: at 1 months
measure: Scar quality at 3 months post surgery
timeFrame: at 3 months
measure: Scar quality at 6 months post surgery
timeFrame: at 6 months
measure: Patient satisfaction at 1 month post surgery
timeFrame: At 1 month
measure: Patient satisfaction at 3 months post surgery
timeFrame: At 3 months
measure: Patient satisfaction at 6 months post surgery
timeFrame: At 6 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hopital Henri Mondor
state: Val De Marne
Study officials:
affiliation: APHP
name: Barbara HERSANT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mommers EHH, Ponten JEH, Al Omar AK, de Vries Reilingh TS, Bouvy ND, Nienhuijs SW. The general surgeon's perspective of rectus diastasis. A systematic review of treatment options. Surg Endosc. 2017 Dec;31(12):4934-4949. doi: 10.1007/s00464-017-5607-9. Epub 2017 Jun 8.
citation: Sperstad JB, Tennfjord MK, Hilde G, Ellstrom-Engh M, Bo K. Diastasis recti abdominis during pregnancy and 12 months after childbirth: prevalence, risk factors and report of lumbopelvic pain. Br J Sports Med. 2016 Sep;50(17):1092-6. doi: 10.1136/bjsports-2016-096065. Epub 2016 Jun 20.
citation: Akram J, Matzen SH. Rectus abdominis diastasis. J Plast Surg Hand Surg. 2014 Jun;48(3):163-9. doi: 10.3109/2000656X.2013.859145. Epub 2013 Nov 21.
citation: Orthopoulos G, Kudsi OY. Feasibility of Robotic-Assisted Transabdominal Preperitoneal Ventral Hernia Repair. J Laparoendosc Adv Surg Tech A. 2018 Apr;28(4):434-438. doi: 10.1089/lap.2017.0595. Epub 2018 Jan 2.
citation: Sugiyama G, Chivukula S, Chung PJ, Alfonso A. Robot-Assisted Transabdominal Preperitoneal Ventral Hernia Repair. JSLS. 2015 Oct-Dec;19(4):e2015.00092. doi: 10.4293/JSLS.2015.00092.
citation: Nahabedian MY. Management Strategies for Diastasis Recti. Semin Plast Surg. 2018 Aug;32(3):147-154. doi: 10.1055/s-0038-1661380. Epub 2018 Jul 24.
citation: Beer GM, Schuster A, Seifert B, Manestar M, Mihic-Probst D, Weber SA. The normal width of the linea alba in nulliparous women. Clin Anat. 2009 Sep;22(6):706-11. doi: 10.1002/ca.20836.
citation: Bellido Luque J, Bellido Luque A, Valdivia J, Suarez Grau JM, Gomez Menchero J, Garcia Moreno J, Guadalajara Jurado J. Totally endoscopic surgery on diastasis recti associated with midline hernias. The advantages of a minimally invasive approach. Prospective cohort study. Hernia. 2015 Jun;19(3):493-501. doi: 10.1007/s10029-014-1300-2. Epub 2014 Aug 21.
citation: Driver VR, Hanft J, Fylling CP, Beriou JM; Autologel Diabetic Foot Ulcer Study Group. A prospective, randomized, controlled trial of autologous platelet-rich plasma gel for the treatment of diabetic foot ulcers. Ostomy Wound Manage. 2006 Jun;52(6):68-70, 72, 74 passim.