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

NCT ID: NCT04915014

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-23

Study Completion Date

2025-07-31

Brief Summary

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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

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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

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Severe Obesity

Keywords

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Severe obesity Type 2 diabetes Metabolic syndrome Surgery Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laparoscopic sleeve gastrectomy with transit bipartition (SG +TB)

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

Group Type EXPERIMENTAL

sleeve gastrectomy with transit bipartition (SG +TB)

Intervention Type PROCEDURE

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.

laparoscopic Roux-en-Y gastric bypass (RYGB)

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

Group Type SHAM_COMPARATOR

Roux-en-Y gastric bypass (RYGB)

Intervention Type PROCEDURE

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.

Interventions

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sleeve gastrectomy with transit bipartition (SG +TB)

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

Roux-en-Y gastric bypass (RYGB)

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert CAIAZZO, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Claude Huriez Chu Lille

Lille, , France

Site Status RECRUITING

CHU de Lyon

Lyon, , France

Site Status RECRUITING

CHU de Nantes

Nantes, , France

Site Status RECRUITING

CHU Orléans

Orléans, , France

Site Status RECRUITING

AP-HP Hôpital Bichat

Paris, , France

Site Status RECRUITING

AP-HP Hôpital Georges Pompidou

Paris, , France

Site Status RECRUITING

CHU de Poitiers

Poitiers, , France

Site Status RECRUITING

CHU de Nancy

Vandœuvre-lès-Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Robert CAIAZZO, MD,PhD

Role: CONTACT

Phone: 0320445962

Email: [email protected]

Facility Contacts

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Role: primary

Maud RoberT, MD, PhD

Role: primary

Claire Blanchard, MD, PhD

Role: primary

Adel Abou Mrad, MD, PhD

Role: primary

Tigran Poghosyan, MD, PhD

Role: primary

Lionel Rebibo, MD, PhD

Role: primary

Jean-Pierre Faure, MD, PhD

Role: primary

Laurent Brunaud, MD, PhD

Role: primary

Other Identifiers

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2020-A02656-33

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC-19-031

Identifier Type: OTHER

Identifier Source: secondary_id

2020_10

Identifier Type: -

Identifier Source: org_study_id