- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02973009
Impact of the Systematic Closure of the Epigastric Trocar on Postoperative Incisional Hernia After Sleeve Gastrectomy Rate of First Intention. Monocentric Study, Before / After Prospective. (TROCSLEEVE)
The Sleeve Gastrectomy (SG) is a bariatric surgery procedure performed by laparoscopic booming in recent years.
This is an effective intervention on weight loss over the long term with few early postoperative complications and low morbidity in the long term.
Obesity is considered as a risk factor for hernia full after surgery by laparoscopy with a relative risk of 29% in connection with cholecystectomy.
Several series showed a rupture rate on trocar from 0 to 0.7%, but each time with a clinical evaluation.
Recently, it was shown eventrations rate between 26 and 38% under the Roux-en-Y gastric bypass with a rupture rate increased on epigastric trocar. The assessment in the context of this series was ultrasound.
Recent data suggest that the absence of closure of the epigastric trocar of 12mm through an SG of first intention was associated with a hernia rate of 17% with a scannographic evaluation.
Also, recently, Tabone suggests that the systematic closure of the epigastric trocar site would not be as effective as lateralize inserting the trocar from the white line of the abdomen. Change the positioning of this trocar induce an additional difficulty in handling instruments for the realization of the SG with an désaxassion instruments, a conflict between the instruments for the realization of the SG and the optical laparoscopy.
Study Overview
Status
Conditions
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- major patients (≥ 18 years) who underwent SG 1st intention by laparoscopy as part of the surgical management of obesity.
Exclusion Criteria:
- antecedent of previous gastric band.
- History of SG (repeat-SG).
- median laparotomy history or subcostal right.
- SG performed as an ambulatory surgery.
- Patients with early postoperative complications (≤ J90) specific to the SG (postoperative gastric fistula, postoperative bleeding, hematoma or postoperative intra-abdominal abscess)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
systematic closure of the epigastric trocar
Time Frame: 1 year
|
Test the hypothesis that the systematic closure of the epigastric trocar 12 mm would reduce by three the number of rupture on epigastric trocar after SG first intent
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rate of incisional hernia.
Time Frame: 1 year
|
Evaluate the rate of incisional hernia at 1 year after 1st SG intention.
|
1 year
|
rate of rupture opposite
Time Frame: 1 year
|
To evaluate the rate of rupture opposite the closure of the open laparoscopy incision closed using the conventional technique (Deguines JB, Qassemyar Q Dhahri A Brehant O, Fuks D Verhaeghe P Regimbeau JM.
Technique of open laparoscopy .. for supramesocolic surgery in obese patients Surg Endosc 2010 Aug; 24 (8): 2053-5) from the rupture rate over the epigastric port with the use of WECK EFx ™ (Teleflex Medical SAS, F-31460 the Faget, France).
|
1 year
|
Morbidity
Time Frame: 1 year
|
Morbidity related to the closing act of the epigastric trocar (organ wound, local hematoma, surgical site infection).
|
1 year
|
duration of the closure of the epigastric trocar.
Time Frame: during surgery
|
Evaluation of the duration of the closure of the epigastric trocar.
|
during surgery
|
duration of the implementation of the device
Time Frame: 1 year
|
Analysis of the evolution of the duration of the implementation of the device
|
1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean-Marc REGIMBEAU, professor, CHU Amiens-Picardie
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2016_843_0031
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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