Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
50 participants
OBSERVATIONAL
2020-01-02
2023-09-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cost-effectiveness Comparison Between Vaginal Versus Robotic Mesh Surgery for Apical Prolapse: Prospective, Cohort Study
NCT03878056
Validation Study for Robotic Surgery Simulator
NCT01618994
Robotic Assisted Sacral Colpopexy : A Prospective Study Assessing Outcomes With Learning Curves
NCT01535833
Robotic-assisted Laparoscopic Sacrocolpopexy
NCT00581334
Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy
NCT05969067
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Diastasis of the rectus abdominis muscles
Diastasis of the rectus abdominis muscles repair using the Intuitiv SI robot
Robotic-assisted diastasis of the rectus abdominis muscles repair
Diastasis of the rectus abdominis muscles repair using the Intuitiv SI robot
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Robotic-assisted diastasis of the rectus abdominis muscles repair
Diastasis of the rectus abdominis muscles repair using the Intuitiv SI robot
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Barbara HERSANT
Role: PRINCIPAL_INVESTIGATOR
APHP
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hopital Henri Mondor
Créteil, Val De Marne, France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Barbara Hersant
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APHP190484
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.