Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity (QUALISLEEVE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2012 by University Hospital, Montpellier
Sponsor:
Collaborators:
University Hospital, Marseille
Centre Hospitalier Universitaire de Nice
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01550601
First received: February 27, 2012
Last updated: March 9, 2012
Last verified: March 2012

February 27, 2012
March 9, 2012
September 2011
April 2014   (final data collection date for primary outcome measure)
Comparison of the frequency appearance of RGO after surgery intervention (between two techniques longitudinal gastrectomy) in patients of morbid obesity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01550601 on ClinicalTrials.gov Archive Site
  • Assessment of efficiency on loss of weight and global post-operative morbidity between both surgery techniques. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Assess the variations of the gastrinaemia according to the used technique (in fact, this hormone is partially secreted by the gastric antrum)
Same as current
Not Provided
Not Provided
 
Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity
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, Multicentrique Study.

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

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Obesity, Morbid
Device: bariatric surgery
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.
  • bariatric surgery 1
    Longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery. In this arm, patients have a bariatric surgery with conservation of gastric antrum.
    Intervention: Device: bariatric surgery
  • Experimental: bariatric surgery 2
    Longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery. In this arm, patients have a bariatric surgery with ablation of gastric antrum.
    Intervention: Device: bariatric surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
346
October 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients with an indication of bariatric surgery (Recommendations HAS) defined as follows:

  • IMC = 40kg/m² with failure of the dietary treatments during at least 1 year, or
  • IMC = 35kg/m ² if associated comorbidity (HTA, diabetes, gonarthrose, sleep apnea, dyslipidemia, severe respiratory diseases)
  • Patients motivated by this surgery and to accept the post-operative constraints.
  • Age: > 18 years and < 65 years.
  • patient having received an favorable opinion to the multidisciplinary meeting
  • patient with his/her consent.
  • patient with French insurance

Exclusion Criteria:

  • Women Patients presenting a current pregnancy (not effective contraception during the first year after surgery) or in age to procreate and without means of effective contraception (oestroprogestational)
  • patient with a contraindication to the anesthesia
  • patient with grave psychiatric disorders (psychotic, paranoid)
  • Emotionally unstable Patient or showing psychiatric characteristics which according to the opinion of the psychologist or the surgeon are incompatible with this type of surgery
  • patient with surgical histories esogastric
  • Patient with an inflammation of the digestive system (severe esophagitis, gastrointestinal ulcer, CROHN disease)
  • Patient with a severe cardiopulmonary affection or other severe organic affection
  • patient with a risk of bleedings in the superior gastrointestinal part (esophageal varice)
  • Patient with gastrointestinal congenital defects (stenosis, atresia)
  • Patient with chronic alcoholism or drug addiction
  • patient having a serious infection (HIV)
  • Patient who refuses categorically the diet imposed by this surgery
  • patient with a food of type "sweet eaters" (sweet food, high calorie liquid).
Both
18 Years to 65 Years
No
Contact: Nocca David, PU-PH 04 67 33 77 31 d-nocca@chu-montpellier.fr
France
 
NCT01550601
8643, 2010-A01021-38
No
University Hospital, Montpellier
University Hospital, Montpellier
  • University Hospital, Marseille
  • Centre Hospitalier Universitaire de Nice
Principal Investigator: Nocca David, PU-PH CHRU de Montpellier
University Hospital, Montpellier
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP