跳至主要内容
临床试验/NCT02973009
NCT02973009撤回不适用

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.

Centre Hospitalier Universitaire, Amiens0 个研究点开始时间: 2017年5月16日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
systematic closure of the epigastric trocar

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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)

结局指标

主要结局

systematic closure of the epigastric trocar

时间窗: 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

次要结局

  • rate of rupture opposite(1 year)
  • rate of incisional hernia.(1 year)
  • Morbidity(1 year)
  • duration of the closure of the epigastric trocar.(during surgery)
  • duration of the implementation of the device(1 year)

研究者

申办方类型
Other
责任方
Sponsor

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