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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University Hospital, Montpellier.
Recruitment status was  Recruiting
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
  Purpose

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


Condition Intervention Phase
Obesity, Morbid
Device: bariatric surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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, Multicentrique Study.

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 346
Study Start Date: September 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
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.

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550601

Contacts
Contact: Nocca David, PU-PH 04 67 33 77 31 d-nocca@chu-montpellier.fr

Locations
France
CHRU Montpellier, Hopital Saint-Eloi Recruiting
Montpellier, France, 34295
Contact: Nocca David, PU-PH    04 67 33 77 31    d-nocca@chu-montpellier.fr   
Principal Investigator: Nocca Davis, PU-PH         
Sponsors and Collaborators
University Hospital, Montpellier
University Hospital, Marseille
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Nocca David, PU-PH CHRU de Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01550601     History of Changes
Other Study ID Numbers: 8643, 2010-A01021-38
Study First Received: February 27, 2012
Last Updated: March 9, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Montpellier:
morbid obesity
gastrectomy
gastrinaemia
comorbidity
gastric antrum

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014