AzTrials
AzTrials

Severe ObesityBIPASSNCT04915014

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

A study testing sleeve gastrectomy with transit bipartition (SG +TB) and Roux-en-Y gastric bypass (RYGB) in people with Severe Obesity, run by University Hospital, Lille at 8 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Severe Obesity
What is being tested?
sleeve gastrectomy with transit bipartition (SG +TB) and Roux-en-Y gastric bypass (RYGB)
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
8 sitesFrance
Study dates
23 Jul 2021to Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

France8 sites
  • Hop Claude Huriez Chu Lille

    Lille, 59037

  • CHU de Lyon

    Lyon

  • CHU de Nantes

    Nantes

  • CHU Orléans

    Orléans

  • AP-HP Hôpital Bichat

    Paris

  • AP-HP Hôpital Georges Pompidou

    Paris

  • CHU de Poitiers

    Poitiers

  • CHU de Nancy

    Vandœuvre-lès-Nancy

Other trials in France

About this study

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)

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.

Read the 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.

Conditions
Severe Obesity
Being tested
sleeve gastrectomy with transit bipartition (SG +TB), Roux-en-Y gastric bypass (RYGB)
Keywords
Severe obesity, Type 2 diabetes, Metabolic syndrome, Surgery, Malnutrition
Medical subject headings
Obesity, Morbid, Diabetes Mellitus, Type 2, Metabolic Syndrome, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sleeve gastrectomy with transit bipartition (SG +TB)Procedure or surgery

    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.

  • Roux-en-Y gastric bypass (RYGB)Procedure or surgery

    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.

Study groups in NCT04915014
Study groupRoleWhat they receive
laparoscopic sleeve gastrectomy with transit bipartition (SG +TB)ExperimentalOne arm benefiting from a laparoscopic sleeve gastrectomy with transit bipartition (SG +TB)
Receives: Procedure: sleeve gastrectomy with transit bipartition (SG +TB)
laparoscopic Roux-en-Y gastric bypass (RYGB)Sham comparatorOne arm benefiting from a laparoscopic Roux-en-Y gastric bypass (RYGB)
Receives: Procedure: Roux-en-Y gastric bypass (RYGB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: at 2 years after surgery

Secondary outcomes (16)
  1. Change nutritional status assessment

    Nutritional profil : Hemoglobin (g/l), albumin (g/l), prealbumin (g/l)

    Measured: from baseline (before surgery) to 24 months after surgery

  2. Change in liver status assessment

    Liver parameters ( ALT AST GGT Alkaline phosphatases, Total bilirubin, prothrombin time, urea, creatininemia concentration)

    Measured: from baseline (before surgery) to 24 months after surgery

  3. Change in vitamins status assessment

    vitamins profil (vitamin A B1, B6 B9, B12, C , D and E concentration)

    Measured: from baseline (before surgery) to 24 months after surgery

  4. Change in mineral status assessment

    Mineral profil ( ferritin, potassium, calcium,iron, transferrin, magnesium, selenium, zinc phophore concentration)

    Measured: from baseline (before surgery) to 24 months after surgery

  5. 24-hour steatorrhea quantified at 6 months

    24-hour steatorrhea is assessed to evaluate denutrition, expressed in g of lipid/24hr

    Measured: At 6 months

  6. Evolution of muscle mass assessed by bioelectrical impedance analysis

    muscle mass is assessed to evaluate denutrition.

    Measured: from baseline to 24 months after surgery

  7. Evolution of muscle mass assessed by grip strength test.

    muscle mass is assessed to evaluate denutrition.

    Measured: from baseline to 24 months after surgery

  8. Complications rate within 2 years according to Dindo-Clavien classification

    complications rate is assessed to evaluate safety of the procedure

    Measured: within 2 years

  9. Length of hospital stay defined as the number of days of hospitalization

    length of hospital stay for the surgical procedure

    Measured: up to 2 week

  10. 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)

    Measured: from baseline to 24 months after surgery

  11. Evolution from baseline to 24 months of insulinoresistance defined by HOMA-IR calculated with fasting blood glucose and fasting insulinemia12

    assessment of insulinoresistance

    Measured: from baseline to 24 months

  12. 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

    Measured: from baseline to 24 months after surgery

  13. 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.

    Measured: from baseline to 24 months after surgery

  14. 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.

    Measured: from baseline to 24 months after surgery

  15. 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.

    Measured: from baseline to 24 months after surgery

  16. 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.

    Measured: from baseline to 24 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2021
  2. Study start23 Jul 2021
  3. Primary completionJul 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04915014
Sponsor's protocol ID
2020_10
Other IDs
2020-A02656-33, PHRC-19-031
Acronym
BIPASS
Status last verified
Feb 2026
First submitted
19 May 2021
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing sleeve gastrectomy with transit bipartition (SG +TB) and Roux-en-Y gastric bypass (RYGB) in people with Severe Obesity, run by University Hospital, Lille at 8 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Excess Weight Loss percentage (EWL%) (time frame: at 2 years after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in