Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity (QUALISLEEVE)
Primary Purpose
Obesity, Morbid
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bariatric surgery
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Morbid focused on measuring morbid obesity, gastrectomy, gastrinaemia, comorbidity, gastric antrum
Eligibility 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).
Sites / Locations
- CHRU Montpellier, Hopital Saint-Eloi
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
bariatric surgery 1
bariatric surgery 2
Arm Description
Longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery. In this arm, patients have a bariatric surgery with conservation of gastric antrum.
Longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery. In this arm, patients have a bariatric surgery with ablation of gastric antrum.
Outcomes
Primary Outcome Measures
Comparison of the frequency appearance of RGO after surgery intervention (between two techniques longitudinal gastrectomy) in patients of morbid obesity
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.
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
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)
Assess the variations of the gastrinaemia according to the used technique (in fact, this hormone is partially secreted by the gastric antrum)
Full Information
NCT ID
NCT01550601
First Posted
February 27, 2012
Last Updated
January 7, 2020
Sponsor
University Hospital, Montpellier
Collaborators
University Hospital, Marseille, Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01550601
Brief Title
Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity
Acronym
QUALISLEEVE
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 30, 2011 (Actual)
Primary Completion Date
March 28, 2017 (Actual)
Study Completion Date
May 17, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
University Hospital, Marseille, Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
morbid obesity, gastrectomy, gastrinaemia, comorbidity, gastric antrum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
346 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bariatric surgery 1
Arm Type
Other
Arm Description
Longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery. In this arm, patients have a bariatric surgery with conservation of gastric antrum.
Arm Title
bariatric surgery 2
Arm Type
Experimental
Arm Description
Longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery. In this arm, patients have a bariatric surgery with ablation of gastric antrum.
Intervention Type
Procedure
Intervention Name(s)
bariatric surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of the frequency appearance of RGO after surgery intervention (between two techniques longitudinal gastrectomy) in patients of morbid obesity
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Assessment of efficiency on loss of weight and global post-operative morbidity between both surgery techniques.
Description
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
Time Frame
12 months
Title
Impact assessment of both types' surgery on the comorbidity and treatments of obesity
Description
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)
Time Frame
12 months
Title
Assessment of gastrinemia between both groups (efficacy assessment)
Description
Assess the variations of the gastrinaemia according to the used technique (in fact, this hormone is partially secreted by the gastric antrum)
Time Frame
at 1,3,12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nocca David, PU-PH
Organizational Affiliation
CHRU de Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Montpellier, Hopital Saint-Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
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Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity
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