Clinical trial NCT03610256: Single-anastomosis Duodeno Ileal Bypass (SADI) Versus Roux-en-Y Gastric Bypass
Official title: Prospective Multicentric Randomized Trial Comparing the Efficacy and Safety of Single-anastomosis Duodeno Ileal Bypass With Sleeve Gastrectomy (SADI-S) Versus Roux-en-Y Gastric Bypass (RYGB)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Keywords: Obesity
Bariatric surgery
Single-anastomosis duodeno ileal bypass (SADI)
Roux-en-Y Gastric Bypass
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. Nowadays, France is ranked 3rd in terms of bariatric surgeries performed per year.

Since the laparoscopic Roux-en-Y gastric bypass (RYGB) was described in 1977, this restrictive and malabsorptive procedure has become a gold standard for morbid obesity with an average Excess Weight Loss % (EWL%) of 72% at 2 years, and a strong metabolic effect, especially with regard to type 2 diabetes remission. Nevertheless, failures are observed (up to 20%), particularly in super obese patients, which are then difficult to manage. In this population, biliopancreatic diversion with duodenal switch (BPD-DS) is indicated due to its stronger weight loss and metabolic effect, but is still little performed worldwide because of its higher morbidity, surgical complexity and risk of malnutrition.

A novel technique combining the physiological advantages of pylorus preservation and the technical benefits of single-loop reconstruction was introduced in 2007 by Sanchez-Pernaute, who described the single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) as an evolution of the BPD-DS. With a 2.5-meter common channel, SADI-S seems to offer good results for the treatment of both morbid obesity and its metabolic complications, with an EWL% of up to 95% at 2 years and potentially less nutritional consequences.

To date, there is only one Spanish randomized trial comparing SADI-S to BPD-DS, whereas BPD-DS represents less than 1% of bariatric procedures in France and is only allowed in super obese patients. Thus only preliminary data of poor scientific value exists. Nevertheless, facing very encouraging short-term outcomes, there is a real need for a prospective trial comparing SADI-S to a standard bariatric procedure.

The aim of the investigator's study is to assess weight loss efficiency and the morbi-mortality of the SADI-S in comparison to a standard (RYGB), in order to validate this procedure among bariatric techniques

HYPOTHESIS SADI-S is superior to the standard RYGB for weight loss, increasing the EWL% by 10% (82% vs 72%, respectively) at 2 years.


Eligibility criteria: Inclusion Criteria:

* Patient aged between 18 and 65 years old,
* Morbid obesity with BMI ≥40 kg/m2 or BMI ≥35 kg/m2 associated with one co-morbidity which will be improved by surgery (high blood pressure, type 2 diabetes mellitus, obstructive sleep apnea, dyslipidemia, arthrosis)
* Patient who has benefited from an upper GI endoscopy with biopsies to look for Helicobacter pylori , within the 12 months before surgery,
* Patient who has benefited from a pluridisciplinary evaluation, with a favorable opinion for SADI-S or RYGB as a primary surgery or after failure of sleeve gastrectomy (defined as insufficient weight loss at 18 months after surgery (EWL% \<50), or as weight regain (+ 20%)).
* 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 with a healthcare insurance plan.

Exclusion Criteria:

* History of previous bariatric surgery, other than a sleeve gastrectomy,
* Presence of a severe and evolutive life threatening pathology, unrelated to obesity,
* History of type 1 diabete,
* History of chronic inflammatory bowel disease,
* Pregnancy or desire to be pregnant during the study,
* Presence of Helicobacter pylori resistant to medical treatment,
* Presence of a unhealed gastro-duodenal ulcer or diagnosed less than 2 months previously,
* Mentally unbalanced patients, 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

Primary outcomes:
measure: Excess Weight Loss measurement
timeFrame: 2 years after surgery
Secondary outcomes:
measure: Albumin
timeFrame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
measure: Pre-albumin
timeFrame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
measure: Hemoglobin
timeFrame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
measure: Calcium
timeFrame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
measure: Ferritin
timeFrame: At each study visit (before surgey and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
measure: Iron
timeFrame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
measure: % of transferrin saturation
timeFrame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
measure: Vitamin A
timeFrame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
measure: Vitamin B1
timeFrame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
measure: Vitamin B12
timeFrame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
measure: Vitamin B9
timeFrame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
measure: Vitamin D
timeFrame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
measure: Vitamin C
timeFrame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
measure: Vitamin E
timeFrame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
measure: Prothrombin rate
timeFrame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
measure: Steatorrhea rate
timeFrame: 6 month after surgery
measure: Average number of stools per day
timeFrame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
measure: HbA1c
timeFrame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
measure: Fasting glycemia
timeFrame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
measure: HDL
timeFrame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
measure: LDL
timeFrame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
measure: Cholesterol
timeFrame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
measure: Triglycerides
timeFrame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
measure: Antidiabetic drugs
timeFrame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
measure: Antilipidemic drugs
timeFrame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
measure: Antihypertensive drugs
timeFrame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
measure: Use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea
timeFrame: Before surgery and 6, 12, 24, 60 and 120 months after surgery
measure: Length of stay
timeFrame: End of the hospitalization period
measure: Readmission of patient
timeFrame: 30 days after surgery
measure: Occurrence of kidney stones
timeFrame: Within 10 years after surgery
measure: Overall complication rate
timeFrame: Within 10 years after surgery
measure: Type and severity of early complications
timeFrame: Within 30 days after surgery
measure: Type and severity of late complications
timeFrame: Within 10 years after surgery
measure: Gastroesophageal reflux assessment
timeFrame: At each study visit (before surgery and 1, 3, 6, 12,18, 24, 60 and 120 months after surgery)
measure: Absolute weight loss assessment
timeFrame: 1, 3, 6, 12, 18, 24, 60 and 120 months after surgery
measure: Excess Weight Loss percentage assessment
timeFrame: 1, 3, 6, 12, 18, 24, 60 and 120 months after surgery
measure: Excess BMI Loss percentage assessment
timeFrame: 1, 3, 6, 12, 18, 24, 60 and 120 months after surgery
measure: Quality of life assessed with GIQLI questionnaire
timeFrame: Before surgery and at 6, 12 and 24 months after surgery
measure: Quality of life assessed with SF36 questionnaire
timeFrame: Before surgery and at 6, 12 and 24 months after surgery
measure: Quality of life assessed with Sigstad questionnaire
timeFrame: Before surgery and at 1, 3, 6, 12, 24, 60 and 120 months after surgery
measure: Evolution of food choices and preferences within 2 years after surgery
timeFrame: Before surgery and 3, 12 and 24 months after surgery
measure: Modifications of the gastric and esophageal mucosa
timeFrame: 60 and 120 months after surgery
measure: Number of reflux episodes
timeFrame: 60 and 120 months after surgery
measure: Number of reflux episodes lasting more than 5 minutes
timeFrame: 60 and 120 months after surgery
measure: Exposure time with pH < 4
timeFrame: 60 and 120 months after surgery
measure: Number of acid refluxes
timeFrame: 60 and 120 months after surgery
measure: Number of non-acid refluxes
timeFrame: 60 and 120 months after surgery
measure: Number of poor acid reflux
timeFrame: 60 and 120 months after surgery
measure: Association with symptoms
timeFrame: 60 and 120 months after surgery
Other outcomes:
Locations:
city: Angers
country: France
facility: Département de Chirurgie Digestive et Viscérale - Clinique de l'Anjou
city: Bordeaux
country: France
facility: Service de Chirurgie Digestive et Endocrinienne - Groupe Hospitalier Pellegrin
city: Bourg-de-Péage
country: France
facility: Service de Chirurgie Digestive et Viscérale - Clinique La Parisière
city: Brignoles
country: France
facility: Département de Chirurgie Digestive et Viscérale, Centre Hospitalier Jean Marcel
city: Cergy-Pontoise
country: France
facility: Département de Chirurgie Digestive, Centre Hospitalier René Dubos
city: Colmar
country: France
facility: Département de Chirurgie Digestive et Thoracique, Hôpitaux Civils de Colmar
city: Colombes
country: France
facility: Service de Chirurgie Générale et Digestive - Hôpital Louis Mourier
city: Créteil
country: France
facility: Service de Chirurgie Digestive - Centre Hospitalier Intercommunal de Créteil
city: Grenoble
country: France
facility: Département de Chirurgie Digestive - CHU Grenoble
city: Lille
country: France
facility: Service de Chirurgie Générale et Endocrinienne - Hôpital Huriez
city: Lyon
country: France
facility: Service de Chirurgie Digestive et Bariatrique - Hôpital Edouard Herriot - HCL
city: Nantes
country: France
facility: Service de Chirurgie Digestive et Endocrinienne - Hôtel Dieu
city: Nice
country: France
facility: Service de Chirurgie Digestive et Transplantation - Hôpital Archet II
city: Paris
country: France
facility: Département de Chirurgie Digestive et Hépatobiliaire - Hôpital Pitié Salpétrière
city: Paris
country: France
facility: Département de Chirurgie Digestive - Institut Mutualiste Montsouris
city: Paris
country: France
facility: Service de Chirurgie Digestive - Hôpital Bichat
city: Paris
country: France
facility: Service de Chirurgie Digestive, Générale et Cancérologique - HEGP
city: Pierre-Bénite
country: France
facility: Service d'Endocrinologie, Diabète et Nutrition - Centre Hospitalier Lyon Sud - HCL
city: Saint Nazaire
country: France
facility: Département de Chirurgie Digestive et Bariatrique, Clinique Mutualiste de l'Estuaire
city: Saint-Grégoire
country: France
facility: Département de Chirurgie Digestive et Hépatobiliaire - Centre Hospitalier Privé Saint Grégoire
city: TOULOUSE Cedex 9
country: France
facility: Service de Chirurgie Digestive, Hôpital Rangueil
city: Vandœuvre-lès-Nancy
country: France
facility: Service de Chirurgie Digestive, Hépatobiliaire et Endocrinienne - Hôpital Brabois adultes
Study officials:
References:
citation: Robert M, Poghosyan T, Delaunay D, Pelascini E, Iceta S, Sterkers A, Barsamian C, Khamphommala L, Bin Dorel S, Maucort-Boulch D, Czernichow S, Disse E. Prospective multicentre randomised trial comparing the efficacy and safety of single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S) versus Roux-en-Y gastric bypass (RYGB): SADISLEEVE study protocol. BMJ Open. 2020 Sep 1;10(9):e037576. doi: 10.1136/bmjopen-2020-037576.