Clinical Trial: Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity: a Prospective,Controlled, Randomized, Mult

Brief Summary:

The bariatric surgery is recognized, at present, as the only effective therapeutic for the patients with morbid obesity. Two surgical procedures (said restrictive) are considered as consensual: the adjustable calibrated horizontal gastroplasty under laparoscopy (ring périgastric) and Gastric Bypass under laparoscopy (LGBP). The longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery recently validated (HAS on 2008). It consists of the realization of a partial gastrectomy of 2/3 (Fundus, gastric Body +/- antrum). However, lot of technical disagreements are brought back by expert teams. The most important disagreement concerns the conservation or the exeresis of the gastric antrum. In fact, the conservation of gastric antrum could facilitate the gastric emptying and to decrease the RGO (main complication) and act on the regulations of hormones modulators of the insulino-secretion.

A prospective,randomized study comparing these both techniques is necessary to determine a unique consensual technique


Detailed Summary:

The main objective of this study is to compare the frequency of post-operative gastronomic appearance of gastroesophageal reflux(RGO) between two techniques of longitudinal gastrectomy under laparoscopy (gastrectomy coupling sleeve with antrum conservation or without antrum conservation) at patients with morbid obesity.

There are lot of secondary outcomes assessed in this study. In fact, one of secondary objectives is to compare between both techniques of longitudinal gastrectomy under laparoscopy described in the literature the efficiency on the loss of weight and global post-operative morbidity.

This study assess the impact of these surgery techniques on the comorbidity of the obesity and their treatments (type 2 diabetes, arterial hypertension, sleep apnea syndrome, arthralgia, dyslipemia).


Sponsor: University Hospital, Montpellier

Current Primary Outcome: Comparison of the frequency appearance of RGO after surgery intervention (between two techniques longitudinal gastrectomy) in patients of morbid obesity [ Time Frame: 12 months ]

The main objective of this study is to compare the frequency of post-operative gastronomic appearance of gastroesophagal reflux(RGO) between both techniques of longitudinal gastrectomy under laparoscopy (gastrectomy coupling sleeve with antrum conservation or without antrum conservation) at patients with morbid obesity.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Assessment of efficiency on loss of weight and global post-operative morbidity between both surgery techniques. [ Time Frame: 12 months ]
    Comparison between both techniques of longitudinal gastrectomy under laparoscopy described in the literature in terms of efficiency on the loss of weight and global post-operative morbidity
  • Impact assessment of both types' surgery on the comorbidity and treatments of obesity [ Time Frame: 12 months ]
    Assess the impact of these surgery techniques on the comorbidity of the obesity and their treatments (type 2 diabetes, arterial hypertension, sleep apnea syndrom, arthralgia, dyslipemia)
  • Assessment of gastrinemia between both groups (efficacy assessment) [ Time Frame: at 1,3,12 months ]
    Assess the variations of the gastrinaemia according to the used technique (in fact, this hormone is partially secreted by the gastric antrum)


Original Secondary Outcome: Same as current

Information By: University Hospital, Montpellier

Dates:
Date Received: February 27, 2012
Date Started: September 2011
Date Completion: October 2014
Last Updated: March 9, 2012
Last Verified: March 2012