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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 (QUALISLEEVE)

Primary Purpose

Obesity, Morbid

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

bariatric surgery

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring morbid obesity, gastrectomy, gastrinaemia, comorbidity, gastric antrum

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

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

Learn more about this trial

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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