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.
Official title: 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 type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Bariatric Surgery
Keywords: The Sleeve Gastrectomy (SG)
bariatric surgery
laparoscopy
systematic closure of the epigastric
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-11-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: major patients who underwent SG 1st intention by laparoscopy as part of the surgical management of obesity

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.


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)

Primary outcomes:
measure: systematic closure of the epigastric trocar
timeFrame: 1 year
Secondary outcomes:
measure: rate of incisional hernia.
timeFrame: 1 year
measure: rate of rupture opposite
timeFrame: 1 year
measure: Morbidity
timeFrame: 1 year
measure: duration of the closure of the epigastric trocar.
timeFrame: during surgery
measure: duration of the implementation of the device
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: CHU amiens-Picardie
name: Jean-Marc REGIMBEAU, professor
role: PRINCIPAL_INVESTIGATOR
References: