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.

NCT ID: NCT02973009

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-16
• Study Completion Date: 2017-05-16

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Marc REGIMBEAU, professor

Role: PRINCIPAL_INVESTIGATOR

CHU amiens-Picardie

Other Identifiers

PI2016_843_0031

Identifier Type: -

Identifier Source: org_study_id