TROCSLEEVE: 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.
Study Details
Study Description
Brief Summary
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.
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Study Design
Outcome Measures
Primary Outcome Measures
- systematic closure of the epigastric trocar [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
Secondary Outcome Measures
- rate of incisional hernia. [1 year]
Evaluate the rate of incisional hernia at 1 year after 1st SG intention.
- rate of rupture opposite [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).
- Morbidity [1 year]
Morbidity related to the closing act of the epigastric trocar (organ wound, local hematoma, surgical site infection).
- duration of the closure of the epigastric trocar. [during surgery]
Evaluation of the duration of the closure of the epigastric trocar.
- duration of the implementation of the device [1 year]
Analysis of the evolution of the duration of the implementation of the device
Eligibility Criteria
Criteria
Inclusion Criteria:
- major patients (≥ 18 years) who underwent SG 1st intention by laparoscopy as part of the surgical management of obesity.
Exclusion Criteria:
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antecedent of previous gastric band.
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History of SG (repeat-SG).
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median laparotomy history or subcostal right.
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SG performed as an ambulatory surgery.
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Patients with early postoperative complications (≤ J90) specific to the SG (postoperative gastric fistula, postoperative bleeding, hematoma or postoperative intra-abdominal abscess)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Centre Hospitalier Universitaire, Amiens
Investigators
- Principal Investigator: Jean-Marc REGIMBEAU, professor, CHU amiens-Picardie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PI2016_843_0031