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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.
This is a bi-centric, prospective, regional research.
Patients will be included in the:
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:
The trial includes: an inclusion visit, a surgical hospitalization and two follow-up visits
An initial inclusion visit,[VI], which allows you to:
Parameters collected during this visit
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:
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diastasis of the rectus abdominis muscles | Diastasis of the rectus abdominis muscles repair using the Intuitiv SI robot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic-assisted diastasis of the rectus abdominis muscles repair | Procedure | Diastasis of the rectus abdominis muscles repair using the Intuitiv SI robot |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average intermuscular distance | Average intermuscular distance post-operatively obtained by averaging ultrasound measurements at the three abdominal points defined by Beer. | At 3 months post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery | Duration of the procedure | During the surgery |
| Hospitalization | Duration of hospitalization | Up to 4 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patient 18 years old or older with an indication for diastasis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara HERSANT, PhD | Contact | + 33 1 49 81 45 33 | barbara.hersant@gmail.com | |
| Jean-Paul MENINGEAUD, PhD | Contact | +33 1 49 81 45 33 | meningaud@me.com |
| Name | Affiliation | Role |
|---|---|---|
| Barbara HERSANT | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Henri Mondor | Recruiting | Créteil | Val De Marne | 94000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28597282 | Background | 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. | |
| 27324871 | Background | 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. |
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| ID | Term |
|---|---|
| D000070630 | Diastasis, Muscle |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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| Drainage | Duration of post-operative drainage | Up to 2 days |
| Complications at 1 month | Occurrence of post-operative complications at 1 month | At 1 month |
| Complications at 3 months | Occurrence of post-operative complications at 3 months | At 3 months |
| Complications at 6 months | Occurrence of post-operative complications at 6 months | At 6 months |
| Scar quality at 1 month post surgery | Evaluation of the scar quality by the POSAS scale | at 1 months |
| Scar quality at 3 months post surgery | Evaluation of the scar quality by the POSAS scale | at 3 months |
| Scar quality at 6 months post surgery | Evaluation of the scar quality by the POSAS scale | at 6 months |
| Patient satisfaction at 1 month post surgery | Overall patient satisfaction with the intervention and outcome | At 1 month |
| Patient satisfaction at 3 months post surgery | Overall patient satisfaction with the intervention and outcome | At 3 months |
| Patient satisfaction at 6 months post surgery | Overall patient satisfaction with the intervention and outcome | At 6 months |
| 24256310 | Background | 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. |
| 29293068 | Background | 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. |
| 26941547 | Background | 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. |
| 30046291 | Background | 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. |
| 19637295 | Background | 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. |
| 25142493 | Background | 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. |
| 16799184 | Background | 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. |