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Sleeve Gastrectomy With Transit Bipartition(SG+TB) Versus Roux-en-Y Gastric Bypass (RYGB) for Type 3 Obesity (BIPASS)

Primary Purpose

Severe Obesity

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sleeve gastrectomy with transit bipartition (SG +TB)
Roux-en-Y gastric bypass (RYGB)
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Obesity focused on measuring Severe obesity, Type 2 diabetes, Metabolic syndrome, Surgery, Malnutrition

Eligibility Criteria

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

Inclusion Criteria:

  • Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for SG+TB or RYGB as a first intention procedure with BMI ≥40 kg/m2 or BMI ≥ 35 kg/m2 associated with one co-morbidity which will be improved by surgery (according to HAS 2009 recommendation3) OR as a second intention procedure (revisional surgery) after failure of Sleeve gastrectomy (defined as insufficient weight loss at 18 months after surgery (EWL% <50), or as weight regain (+ 20%)).
  • Patient who had benefited from an Upper GI Endoscopy with biopsies to look for Helicobacter Pylori (HP) and a HP eradication.
  • Patient who understands and accepts the need for a long-term follow-up
  • Patient who agrees to be included in the study and who signs the informed consent form
  • Patient affiliated to a healthcare insurance plan

Exclusion Criteria:

  • History of previous bariatric surgery, other than a Sleeve Gastrectomy
  • Patient with current BMI > 60 kg/m2
  • Presence of a severe and evolutive life threatening pathology, unrelated to obesity
  • History of Chronic inflammatory bowel disease
  • Type 1 Diabetes
  • Pregnancy or desire to be pregnant during the study
  • Nursing woman
  • Presence of Pylori Helicobacter resistant to medical treatment
  • Presence of a non-healed gastro-duodenal ulcer or diagnosed less than 2 months previously
  • Severe esophagitis (grade C of Los Angeles classification)
  • Hiatal hernia
  • Patients with unstable psychiatric disorder, under supervision or guardianship
  • Patient who does not understand French/ is unable to give consent
  • Patient not affiliated to a French or European healthcare insurance
  • Patient who has already been included in a trial which has a conflict of interests with the present study
  • Patient incarcerated

Sites / Locations

  • Hop Claude Huriez Chu LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

laparoscopic sleeve gastrectomy with transit bipartition (SG +TB)

laparoscopic Roux-en-Y gastric bypass (RYGB)

Arm Description

One arm benefiting from a laparoscopic sleeve gastrectomy with transit bipartition (SG +TB)

One arm benefiting from a laparoscopic Roux-en-Y gastric bypass (RYGB)

Outcomes

Primary Outcome Measures

The Excess Weight Loss percentage (EWL%)
The Excess Weight Loss percentage (EWL%) calculated with the following formula: ((weight at 2 years visit - initial weight (kg)) / (initial weight - ideal weight)) X 100 Ideal weight defined as the weight corresponding to a BMI = 25 kg/m2. Initial weight defined as preoperative weight at V1. All weights are expressed in kg

Secondary Outcome Measures

Change nutritional status assessment
Nutritional profil : Hemoglobin (g/l), albumin (g/l), prealbumin (g/l)
Change in liver status assessment
Liver parameters ( ALT AST GGT Alkaline phosphatases, Total bilirubin, prothrombin time, urea, creatininemia concentration)
Change in vitamins status assessment
vitamins profil (vitamin A B1, B6 B9, B12, C , D and E concentration)
Change in mineral status assessment
Mineral profil ( ferritin, potassium, calcium,iron, transferrin, magnesium, selenium, zinc phophore concentration)
24-hour steatorrhea quantified at 6 months
24-hour steatorrhea is assessed to evaluate denutrition, expressed in g of lipid/24hr
Evolution of muscle mass assessed by bioelectrical impedance analysis
muscle mass is assessed to evaluate denutrition.
Evolution of muscle mass assessed by grip strength test.
muscle mass is assessed to evaluate denutrition.
Complications rate within 2 years according to Dindo-Clavien classification
complications rate is assessed to evaluate safety of the procedure
Length of hospital stay defined as the number of days of hospitalization
length of hospital stay for the surgical procedure
Evolution from baseline to 24 months after surgery of HbA1c level, HDL, LDL and triglycerides
Evolution from baseline to 24 months after surgery of HbA1c level (expressed in %), fasting glycemia (expressed in mmol/l or g/l), HDL (expressed in mmol/l or g/l), LDL (expressed in mmol/l or g/l) and triglycerides (expressed in mmol/l)
Evolution from baseline to 24 months of insulinoresistance defined by HOMA-IR calculated with fasting blood glucose and fasting insulinemia12
assessment of insulinoresistance
Change of the GIQLI score
This questionnaire consists of 36 items exploring 5 dimensions or subscales: symptoms, physical condition, emotions, social integration and the effect of any medical treatment. For each item, 5 responses will be proposed to patients and for each answer, a score is assigned, ranging from 0 to 4 (highest score = 144). A high score defines a more favorable health state
Change of the SF36 scores
This questionnaire taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health.
Change in Sigstad questionnaire score (dumping syndrome).
The Sigstad questionnaire allows the identification and diagnosis of postoperative hypoglycemia: a score > 7 suggests a dumping and a score <4 suggests another diagnosis. Complementary questions regarding timing of dumping (<30 min or >1h30) will be asked if Sigstad score >7.
Change of food choices and preferences assessed by the Leeds Food Preference Questionnaire (LFPQ) score.
The Leeds Food Preference Questionnaire provides measures of different components of food preference and food reward. Participants are presented with an array of pictures of individual food items common in the diet. Foods in the array are chosen by the experimenter from a validated database to be either predominantly high (>50% energy) or low (<20% energy) in fat but similar in familiarity, protein content, sweet or non-sweet taste and palatability. Outcome measured are explicit Liking, explicit wanting, implicit wanting and food choice. Scores for explicit liking and explicit wanting range from 0-100 with a typical mean (±S.D.) of 60±18 Scores for Food Choice range from 0-48 and have a typical mean of 24±10 or for the appeal bias range from -48-48 with a typical mean of -5±15. Scores for Implicit Wanting typically range from -100-100 (due to RT there is no fixed min-max value) and have a typical mean of ±10±25 or for the appeal bias a typical mean of -10±30.
Change of physical activity assessed by the International Physical Activity Index (IPAQ) score.
The International Physical Activity Questionnaire assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives to estimate total physical activity in MET-min/week and time spent sitting.

Full Information

First Posted
May 19, 2021
Last Updated
March 14, 2022
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT04915014
Brief Title
Sleeve Gastrectomy With Transit Bipartition(SG+TB) Versus Roux-en-Y Gastric Bypass (RYGB) for Type 3 Obesity
Acronym
BIPASS
Official Title
Prospective Multicentric Randomized Trial Comparing the Efficacy and Safety of Sleeve Gastrectomy With Transit Bipartition (SG+TB) Versus Roux-en-Y Gastric Bypass (RYGB)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 23, 2021 (Actual)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Obesity is a major public health problem worldwide. Bariatric surgery has proved to be the most effective treatment of morbid obesity in terms of weight reduction and remission of co-morbid conditions during long-term follow-up. Sleeve Gastrectomy (SG) has become the most performed intervention either worldwide or in France, where SG represents more than 60% of bariatric interventions and 114,817 patients operated between 2013 and 2016. Maximum Excess weight loss (%EWL) after SG is obtained at one-year post surgery. Then it has been largely reported in the literature that patients could present mild, moderate or important (notably in the super obese patients) weight regain associated with comorbidity relapse motivating redo surgery. Like in revisional surgery, operating super-obese patient (BMI ≥50 kg/m2) is a challenge. It has been shown that achieving significant weight loss was more difficult in patients with a BMI ≥ 50 compared to lower BMIs.
Detailed Description
In these 2 populations of patients, more malabsorptive procedures like long limb One Anastomosis Gastric Bypass or Bilio-Pancreatic Diversion with Duodenal Switch could be more efficient but induce technical difficulties (high complication rate) and can be responsible for malnutrition (vitamin deficiencies, hypoalbuminemia…). That's why, in case of revisional surgery or for high BMI patients,laparoscopic Roux-en-Y gastric bypass (RYGBP) is still considered as the gold standard and is the most performed intervention. To obtain better weight loss safely,Santoro et al. promoted the sleeve gastrectomy with transit bipartition (SG+TB), a new intervention coupling a SG without interrupting pathway through the duodenum and preserving the pylorus and a long biliary limb RYGBP. Hypothesis: Because there is no duodenal and jejunal exclusion, malnutrition is expected to be less frequent after SG+TB compared to BPD/DS. Its anastomosis on the antrum makes SG+TB easier to perform in super-obese patient than standard RYGB but more efficient in term of weight loss. Compared to BPD/DS or SADI which involves dissection of the duodenum and the confection of a duodenojejunostomy, SG+TB is also expected to be easier then safer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Obesity
Keywords
Severe obesity, Type 2 diabetes, Metabolic syndrome, Surgery, Malnutrition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic sleeve gastrectomy with transit bipartition (SG +TB)
Arm Type
Experimental
Arm Description
One arm benefiting from a laparoscopic sleeve gastrectomy with transit bipartition (SG +TB)
Arm Title
laparoscopic Roux-en-Y gastric bypass (RYGB)
Arm Type
Sham Comparator
Arm Description
One arm benefiting from a laparoscopic Roux-en-Y gastric bypass (RYGB)
Intervention Type
Procedure
Intervention Name(s)
sleeve gastrectomy with transit bipartition (SG +TB)
Intervention Description
In case of a first intention procedure, a typical sleeve gastrectomy is performed, calibrated on a 36 French bougie, stapling starting 4 to 6 cm from the pylorus. Antecolic gastroileal anastomosis is performed 250 cm from the ileocecal transition, on the antrum using a linear stapler (45-mm gold cartridge) or hand-sewn (at least 3 cm wide on the stomach). Laterolateral enteroanastomosis is performed 120 cm from the ileocecal junction. Thus, alimentary limb is 130cm and common limb 120cm.
Intervention Type
Procedure
Intervention Name(s)
Roux-en-Y gastric bypass (RYGB)
Intervention Description
A small gastric pouch (30 cc) is performed. Antecolic gastroileal anastomosis is performed 200 cm from the Treitz junction, using a linear stapler (45-mm gold cartridge) or hand-sewn (at least 3 cm wide on the stomach). Laterolateral enteroanastomosis is performed 50 cm from the Treitz junction. Thus, alimentary limb is 150cm and biliary limb 50cm.
Primary Outcome Measure Information:
Title
The Excess Weight Loss percentage (EWL%)
Description
The Excess Weight Loss percentage (EWL%) calculated with the following formula: ((weight at 2 years visit - initial weight (kg)) / (initial weight - ideal weight)) X 100 Ideal weight defined as the weight corresponding to a BMI = 25 kg/m2. Initial weight defined as preoperative weight at V1. All weights are expressed in kg
Time Frame
at 2 years after surgery
Secondary Outcome Measure Information:
Title
Change nutritional status assessment
Description
Nutritional profil : Hemoglobin (g/l), albumin (g/l), prealbumin (g/l)
Time Frame
from baseline (before surgery) to 24 months after surgery
Title
Change in liver status assessment
Description
Liver parameters ( ALT AST GGT Alkaline phosphatases, Total bilirubin, prothrombin time, urea, creatininemia concentration)
Time Frame
from baseline (before surgery) to 24 months after surgery
Title
Change in vitamins status assessment
Description
vitamins profil (vitamin A B1, B6 B9, B12, C , D and E concentration)
Time Frame
from baseline (before surgery) to 24 months after surgery
Title
Change in mineral status assessment
Description
Mineral profil ( ferritin, potassium, calcium,iron, transferrin, magnesium, selenium, zinc phophore concentration)
Time Frame
from baseline (before surgery) to 24 months after surgery
Title
24-hour steatorrhea quantified at 6 months
Description
24-hour steatorrhea is assessed to evaluate denutrition, expressed in g of lipid/24hr
Time Frame
At 6 months
Title
Evolution of muscle mass assessed by bioelectrical impedance analysis
Description
muscle mass is assessed to evaluate denutrition.
Time Frame
from baseline to 24 months after surgery
Title
Evolution of muscle mass assessed by grip strength test.
Description
muscle mass is assessed to evaluate denutrition.
Time Frame
from baseline to 24 months after surgery
Title
Complications rate within 2 years according to Dindo-Clavien classification
Description
complications rate is assessed to evaluate safety of the procedure
Time Frame
within 2 years
Title
Length of hospital stay defined as the number of days of hospitalization
Description
length of hospital stay for the surgical procedure
Time Frame
up to 2 week
Title
Evolution from baseline to 24 months after surgery of HbA1c level, HDL, LDL and triglycerides
Description
Evolution from baseline to 24 months after surgery of HbA1c level (expressed in %), fasting glycemia (expressed in mmol/l or g/l), HDL (expressed in mmol/l or g/l), LDL (expressed in mmol/l or g/l) and triglycerides (expressed in mmol/l)
Time Frame
from baseline to 24 months after surgery
Title
Evolution from baseline to 24 months of insulinoresistance defined by HOMA-IR calculated with fasting blood glucose and fasting insulinemia12
Description
assessment of insulinoresistance
Time Frame
from baseline to 24 months
Title
Change of the GIQLI score
Description
This questionnaire consists of 36 items exploring 5 dimensions or subscales: symptoms, physical condition, emotions, social integration and the effect of any medical treatment. For each item, 5 responses will be proposed to patients and for each answer, a score is assigned, ranging from 0 to 4 (highest score = 144). A high score defines a more favorable health state
Time Frame
from baseline to 24 months after surgery
Title
Change of the SF36 scores
Description
This questionnaire taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health.
Time Frame
from baseline to 24 months after surgery
Title
Change in Sigstad questionnaire score (dumping syndrome).
Description
The Sigstad questionnaire allows the identification and diagnosis of postoperative hypoglycemia: a score > 7 suggests a dumping and a score <4 suggests another diagnosis. Complementary questions regarding timing of dumping (<30 min or >1h30) will be asked if Sigstad score >7.
Time Frame
from baseline to 24 months after surgery
Title
Change of food choices and preferences assessed by the Leeds Food Preference Questionnaire (LFPQ) score.
Description
The Leeds Food Preference Questionnaire provides measures of different components of food preference and food reward. Participants are presented with an array of pictures of individual food items common in the diet. Foods in the array are chosen by the experimenter from a validated database to be either predominantly high (>50% energy) or low (<20% energy) in fat but similar in familiarity, protein content, sweet or non-sweet taste and palatability. Outcome measured are explicit Liking, explicit wanting, implicit wanting and food choice. Scores for explicit liking and explicit wanting range from 0-100 with a typical mean (±S.D.) of 60±18 Scores for Food Choice range from 0-48 and have a typical mean of 24±10 or for the appeal bias range from -48-48 with a typical mean of -5±15. Scores for Implicit Wanting typically range from -100-100 (due to RT there is no fixed min-max value) and have a typical mean of ±10±25 or for the appeal bias a typical mean of -10±30.
Time Frame
from baseline to 24 months after surgery
Title
Change of physical activity assessed by the International Physical Activity Index (IPAQ) score.
Description
The International Physical Activity Questionnaire assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives to estimate total physical activity in MET-min/week and time spent sitting.
Time Frame
from baseline to 24 months after surgery

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: Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for SG+TB or RYGB as a first intention procedure with BMI ≥40 kg/m2 or BMI ≥ 35 kg/m2 associated with one co-morbidity which will be improved by surgery (according to HAS 2009 recommendation3) OR as a second intention procedure (revisional surgery) after failure of Sleeve gastrectomy (defined as insufficient weight loss at 18 months after surgery (EWL% <50), or as weight regain (+ 20%)). Patient who had benefited from an Upper GI Endoscopy with biopsies to look for Helicobacter Pylori (HP) and a HP eradication. Patient who understands and accepts the need for a long-term follow-up Patient who agrees to be included in the study and who signs the informed consent form Patient affiliated to a healthcare insurance plan Exclusion Criteria: History of previous bariatric surgery, other than a Sleeve Gastrectomy Patient with current BMI > 60 kg/m2 Presence of a severe and evolutive life threatening pathology, unrelated to obesity History of Chronic inflammatory bowel disease Type 1 Diabetes Pregnancy or desire to be pregnant during the study Nursing woman Presence of Pylori Helicobacter resistant to medical treatment Presence of a non-healed gastro-duodenal ulcer or diagnosed less than 2 months previously Severe esophagitis (grade C of Los Angeles classification) Hiatal hernia Patients with unstable psychiatric disorder, under supervision or guardianship Patient who does not understand French/ is unable to give consent Patient not affiliated to a French or European healthcare insurance Patient who has already been included in a trial which has a conflict of interests with the present study Patient incarcerated
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert CAIAZZO, MD,PhD
Phone
0320445962
Ext
+33
Email
robert.caiazzo@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert CAIAZZO, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Claude Huriez Chu Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962

12. IPD Sharing Statement

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Sleeve Gastrectomy With Transit Bipartition(SG+TB) Versus Roux-en-Y Gastric Bypass (RYGB) for Type 3 Obesity

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