NCT01550601

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2017

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2019

Completed
Last Updated

January 10, 2020

Status Verified

January 1, 2020

Enrollment Period

5.5 years

First QC Date

February 27, 2012

Last Update Submit

January 7, 2020

Conditions

Obesity, Morbid

Keywords

morbid obesitygastrectomygastrinaemiacomorbiditygastric antrum

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (3)

  • Assessment of efficiency on loss of weight and global post-operative morbidity between both surgery techniques.

    12 months

  • Impact assessment of both types' surgery on the comorbidity and treatments of obesity

    12 months

  • Assessment of gastrinemia between both groups (efficacy assessment)

    at 1,3,12 months

Study Arms (2)

bariatric surgery 1

OTHER

Longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery. In this arm, patients have a bariatric surgery with conservation of gastric antrum.

Procedure: bariatric surgery

bariatric surgery 2

EXPERIMENTAL

Longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery. In this arm, patients have a bariatric surgery with ablation of gastric antrum.

Procedure: bariatric surgery

Interventions

bariatric surgeryPROCEDURE

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 1bariatric surgery 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Montpellier, Hopital Saint-Eloi

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Nocca David, PU-PH

    CHRU de Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2012

First Posted

March 12, 2012

Study Start

September 30, 2011

Primary Completion

March 28, 2017

Study Completion

May 17, 2019

Last Updated

January 10, 2020

Record last verified: 2020-01

Locations

FR(1)