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.

NCT02973009 | Withdrawn

• 1 other identifier: PI2016_843_0031
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bariatric Surgery

Keywords

The Sleeve Gastrectomy (SG); bariatric surgery; laparoscopy; systematic closure of the epigastric

Outcome Measures

Primary Outcomes (1)

• systematic closure of the epigastric trocar

  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 Outcomes (5)

• rate of incisional hernia.

  1 year

• rate of rupture opposite

  1 year

• Morbidity

  1 year

• duration of the closure of the epigastric trocar.

  during surgery

• duration of the implementation of the device

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

major patients who underwent SG 1st intention by laparoscopy as part of the surgical management of obesity

You may qualify if:

• major patients (≥ 18 years) who underwent SG 1st intention by laparoscopy as part of the surgical management of obesity.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Officials

• Jean-Marc REGIMBEAU, professor

  CHU amiens-Picardie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 25, 2016
• Study Start: May 16, 2017
• Primary Completion: May 16, 2017
• Study Completion: May 16, 2017
• Last Updated: July 15, 2020

Record last verified: 2020-07