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Single-anastomosis Duodeno Ileal Bypass (SADI) Versus Roux-en-Y Gastric Bypass (SADISLEEVE)

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ClinicalTrials.gov Identifier: NCT03610256
Recruitment Status : Recruiting
First Posted : August 1, 2018
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Obesity, Morbid Procedure: SADI-S Procedure: RYGB Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 18, 2018
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arm Intervention/treatment
Experimental: SADI-S

This corresponds to obese patients (BMI ≥40 kg/m2 or BMI ≥35 kg/m2 +/- co-morbidities (high blood pressure, dyslipidemia, obstructive sleep apnea, type 2 diabetes mellitus, arthrosis)) benefiting from a laparoscopic SADI-S (laparoscopic Single-anastomosis duodeno ileal bypass with Sleeve gastrectomy).

SADI-S will be performed as a primary procedure or after failure of sleeve gastrectomy, defined as insufficient weight loss at 18 months after surgery (EWL% <50), or as weight regain (+ 20% of nadir weight).

Procedure: SADI-S
Laparoscopic SADI-S, recently described as an evolution of the BPD-DS, combining the physiological advantages of pylorus preservation and the technical benefits of single-loop reconstruction, associating a sleeve gastrectomy and a duodeno-ileal bypass at 2.5 meters from the ileo-caecal valve if BMI ≥ 50 kg/m² or at 3 meters if BMI < 50
Other Name: Laparoscopic Single-anastomosis duodeno ileal bypass with Sleeve gastrectomy (SADI-S)

Active Comparator: RYGB

This corresponds to obese patients (BMI ≥40 kg/m2 or BMI ≥35 kg/m2 +/- co-morbidities (high blood pressure, dyslipidemia, obstructive sleep apnea, type 2 diabetes mellitus, arthrosis)) benefiting from a laparoscopic RYGB (laparoscopic Roux-en-Y Gastric ByPass).

Similarly to the experimental group, RYGB will be performed as a primary procedure or after failure of sleeve gastrectomy, which is defined as insufficient weight loss at 18 months after surgery (EWL% <50), or as weight regain (+ 20% of nadir weight).

Procedure: RYGB

The laparoscopic Roux-en-Y Gastric Bypass will consist of:

  • a small gastric pouch (about 30cc)
  • an antecolic alimentary limb
  • a gastro-jejunal anastomosis using a linear stapler
  • a 150cm long alimentary limb
  • a 50cm biliary limb
  • a latero-lateral jejuno-jejunal anastomosis
  • closure of the mesenteric defects
Other Name: Roux-en-Y Gastric ByPass




Primary Outcome Measures :
  1. Excess Weight Loss measurement [ Time Frame: 2 years after surgery ]

    For each surgical procedure, weight loss will be assessed 2 years after surgery using Excess Weight Loss percentage (EWL%), calculated using the following formula:

    ((weight at 2-year visit - initial weight) / (initial weight - ideal weight)) X 100 The assessment of the primary endpoint will be standardized between the centers and carried out under blind conditions.



Secondary Outcome Measures :
  1. Albumin [ Time Frame: At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery) ]
    Measurement of albumin will explore the nutritional status of patients. Results will be expressed in g/l

  2. Pre-albumin [ Time Frame: At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery) ]
    Measurement of pre-albumin will explore the nutritional status of patients. Results will be expressed in g/l

  3. Hemoglobin [ Time Frame: At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery) ]
    Measurement of Hemoglobin will explore the nutritional status of patients. Results will be expressed in g/l

  4. Calcium [ Time Frame: At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery) ]
    Measurement of Calcium will explore the nutritional status of patients. Results will be expressed in mmol/l

  5. Ferritin [ Time Frame: At each study visit (before surgey and 1, 3, 6, 12, 18 and 24 months after surgery) ]
    Measurement of ferritin will explore the nutritional status of patients. Results will be expressed in microg/l

  6. Iron [ Time Frame: At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery) ]
    Measurement of iron will explore the nutritional status of patients. Results will be expressed in micromol/l

  7. % of transferrin saturation [ Time Frame: At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery) ]
    Measurement of % of transferrin saturation will explore the nutritional status of patients. Results will be expressed in %

  8. Vitamin A [ Time Frame: Before surgery and 6, 12 and 24 months after surgery ]
    Measurement of vitamin A will explore the nutritional status of patients. Results will be expressed in micromol/l

  9. Vitamin B1 [ Time Frame: Before surgery and 6, 12 and 24 months after surgery ]
    Measurement of vitamin B1 will explore the nutritional status of patients. Results will be expressed in nmol/l

  10. Vitamin B12 [ Time Frame: Before surgery and 6, 12 and 24 months after surgery ]
    Measurement of vitamin B12 will explore the nutritional status of patients. Results will be expressed in pmol/l

  11. Vitamin B9 [ Time Frame: Before surgery and 6, 12 and 24 months after surgery ]
    Measurement of vitamin B9 will explore the nutritional status of patients. Results will be expressed in nmol/l

  12. Vitamin D [ Time Frame: Before surgery and 6, 12 and 24 months after surgery ]
    Measurement of vitamin D will explore the nutritional status of patients. Results will be expressed in nmol/l

  13. Vitamin C [ Time Frame: Before surgery and 6, 12 and 24 months after surgery ]
    Measurement of vitamin C will explore the nutritional status of patients. Results will be expressed in micromol/l

  14. Vitamin E [ Time Frame: Before surgery and 6, 12 and 24 months after surgery ]
    Measurement of vitamin E will explore the nutritional status of patients. Results will be expressed in micromol/l

  15. Prothrombin rate [ Time Frame: Before surgery and 6, 12 and 24 months after surgery ]
    Measurement of prothrombine rate will explore the nutritional status of patients. Results will be expressed in %

  16. Steatorrhea rate [ Time Frame: 6 month after surgery ]
    Measurement of the 24-hour steatorrhea rate will explore the nutritional status of patients. Results will be expressed in grams of lipids /100g of stools

  17. Average number of stools per day [ Time Frame: At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery) ]
    Measurement of the average number of stool will explore the nutritional status of patients. Results will be expressed in number of stool/day

  18. HbA1c [ Time Frame: At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery) ]
    Measurement of HbA1c will explore the Metabolic efficiency of surgery. Results will be expressed in %

  19. Fasting glycemia [ Time Frame: At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery) ]
    Measurement of fasting glycemia will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l

  20. HDL [ Time Frame: At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery) ]
    Measurement of HDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l

  21. LDL [ Time Frame: At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery) ]
    Measurement of LDL will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l

  22. Cholesterol [ Time Frame: At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery) ]
    Measurement of cholesterol will explore the Metabolic efficiency of surgery. Results will be expressed in mmol/l

  23. Triglycerides [ Time Frame: At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery) ]
    Measurement of triglycerides will explore the Metabolic of surgery. Results will be expressed in mmol/l

  24. Antidiabetic drugs [ Time Frame: Before surgery and 6, 12 and 24 months after surgery ]
    Evolution of antidiabetic drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.

  25. Antilipidemic drugs [ Time Frame: Before surgery and 6, 12 and 24 months after surgery ]
    Evolution of antilipidemic drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.

  26. Antihypertensive drugs [ Time Frame: Before surgery and 6, 12 and 24 months after surgery ]
    Evolution of antihypertensive drugs will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of increase, decrease, discontinuation or restart of treatment.

  27. Use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea [ Time Frame: Before surgery and 6, 12 and 24 months after surgery ]
    Evolution of the use of Continuous Positive Airway Pressure for Obstructive Sleep Apnea will explore the Metabolic efficiency of surgery. This outcome will be expressed in terms of persistence or not of obstructive sleep apnea.

  28. Length of stay [ Time Frame: End of the hospitalization period ]
    The Length of stay (in days) is based on the number of days of hospitalization from surgery (day of surgery = D0) until the end of hospitalization.

  29. Readmission of patient [ Time Frame: 30 days after surgery ]
    Number of patients readmitted within 30 days after surgery.

  30. Occurrence of kidney stones [ Time Frame: Within 2 years after surgery ]
    For each visit after the surgery, the presence or not of kidney stones will be documented and if applicable the treatment will be noted

  31. Overall complication rate [ Time Frame: Within 2 years after surgery ]

    Rate of medical and surgical (> or = grade 3) complications within 24 months after surgery using the Dindo-Clavien classification, described as :

    Grade I = Any deviation from the normal postoperative course. Grade 2 = Requiring pharmacological treatment with drugs other than such allowed for grade I complications.

    Grade III = Requiring surgical, endoscopic or radiological intervention, not under (Grade IIIa) or under general anesthesia (Grade IIIb) Grade IV = Life-threatening complication with single organ (Grade IVa) or Multiorgan dysfunction (Grade IVb) Grade V = Death of a patient.


  32. Type and severity of early complications [ Time Frame: Within 30 days after surgery ]
    Type (medical or surgical) and severity of early complications (within 30 days) for each procedure according to the Dindo-Clavien classification (description of this classification was made in outcome 32).

  33. Type and severity of late complications [ Time Frame: Within 2 years after surgery ]
    Type (medical or surgical) and severity of late complications (after 30 days) for each procedure according to the Dindo-Clavien classification (description of this classification was made in outcome 32).

  34. Gastroesophageal reflux assessment [ Time Frame: At each study visit (before surgery and 1, 3, 6, 12, 18 and 24 months after surgery) ]
    Evolution of gastroesophageal reflux will be assessed at each study visit, before and after surgery. This outcome will be expressed in terms of improvement, aggravation or onset.

  35. Absolute weight loss assessment [ Time Frame: 1, 3, 6, 12, 18 and 24 months after surgery ]
    Weight loss at 1, 3, 6, 12, 18 and 24 months after surgery, according to absolute weight loss (aWL) in kg.

  36. Excess Weight Loss percentage assessment [ Time Frame: 1, 3, 6, 12, 18 and 24 months after surgery ]

    Weight loss at 1, 3, 6, 12, 18 and 24 months after surgery, according to Excess Weight Loss percentage (EWL%), calculated using the following formula:

    ((weight at visit X - initial weight) / (initial weight - ideal weight)) X 100


  37. Excess BMI Loss percentage assessment [ Time Frame: 1, 3, 6, 12, 18 and 24 months after surgery ]

    Weight loss at 1, 3, 6, 12, 18 and 24 months after surgery, according Excess BMI Loss percentage (EBL%), according to the formula :

    ((BMI at visit X - initial BMI) / (initial BMI - ideal BMI)) X 100 with Ideal BMI = 25 kg/m²


  38. Quality of life assessed with GIQLI questionnaire [ Time Frame: Before surgery and at 6, 12 and 24 months after surgery ]

    Before surgery and at 6, 12 and 24 months after surgery, according to the GIQLI questionnaire.

    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 the patients and for each answer, a score ranging from 0 to 4 (highest score = 144) will be assigned. A high score defines a more favorable health state.


  39. Quality of life assessed with SF36 questionnaire [ Time Frame: Before surgery and at 6, 12 and 24 months after surgery ]

    Before surgery and at 6, 12 and 24 months after surgery, according to the SF36 questionnaire.

    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/tiredness, and general health perceptions. It also includes a single item that provides an indication of a perceived change in health


  40. Quality of life assessed with Sigstad questionnaire [ Time Frame: Before surgery and at 1, 3, 6, 12 and 24 months after surgery ]

    Sigstad questionnaire for all postoperative study visits (except 18 months after surgery).

    The Sigstad questionnaire allows the identification and diagnosis of postoperative dumping syndrome and early hypoglycaemia: a score >7 suggests a dumping syndrome


  41. Evolution of food choices and preferences within 2 years after surgery [ Time Frame: Before surgery and 3, 12 and 24 months after surgery ]

    The evolution of food choices and preferences will be measured before surgery and 3, 12 and 24 months after surgery using a computerized test: the "Leeds Food Preference Questionnaire (LFPQ).

    The Leed Food Preference Questionnaire provides measurements of different components of food preference and food reward, and is a computerized questionnaire. Participants are presented with an array of pictures of individual food items common in the diet. Foods are chosen 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 not-sweet taste and palatability. Responses are recorded and used to compute mean scores for high fat, low fat, sweet or savory food types (and different fat-taste combinations).

    This assessment will be performed only in the coordinating center




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 6 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03610256


Contacts
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Contact: Maud ROBERT, MD 4 72 11 62 63 ext +33 maud.robert@chu-lyon.fr
Contact: Dominique DELAUNAY 4 72 11 00 64 ext +33 dominique.delaunay@chu-lyon.fr

Locations
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France
Département de Chirurgie Digestive et Viscérale - Clinique de l'Anjou Recruiting
Angers, France, 49000
Contact: Philippe TOPART, MD         
Principal Investigator: Philippe TOPART, MD         
Service de Chirurgie Digestive et Métabolique - Hôpital Avicenne - APHP Recruiting
Bobigny, France, 93000
Contact: Christophe BARRAT, MD         
Principal Investigator: Christophe BARRAT, MD         
Service de Chirurgie Digestive et Endocrinienne - Groupe Hospitalier Pellegrin Recruiting
Bordeaux, France, 33076
Contact: Caroline GRONNIER, MD         
Principal Investigator: Caroline GRONNIER, MD         
Service de Chirurgie Digestive et Viscérale - Clinique La Parisière Recruiting
Bourg-de-Péage, France, 26300
Contact: Jean Louis LORIN, MD         
Principal Investigator: Jean Louis LORIN, MD         
Service de Chirurgie Générale et Digestive - Hôpital Louis Mourier Recruiting
Colombes, France, 92700
Contact: Daniela CALABRESE, MD         
Principal Investigator: Daniela CALABRESE, MD         
Service de Chirurgie Digestive - Centre Hospitalier Intercommunal de Créteil Recruiting
Créteil, France, 94000
Contact: Andrea LAZZATI, MD         
Sub-Investigator: Andrea LAZZATI, MD         
Département de Chirurgie Digestive - CHU Grenoble Recruiting
Grenoble, France, 38043
Contact: Fabian RECHE, MD         
Principal Investigator: Fabian RECHE, MD         
Service de Chirurgie Générale et Endocrinienne - Hôpital Huriez Recruiting
Lille, France, 59037
Contact: Robert CAIAZZO, MD         
Principal Investigator: Robert CAIAZZO, MD         
Service de Chirurgie Digestive et Bariatrique - Hôpital Edouard Herriot - HCL Recruiting
Lyon, France, 69437
Contact: Maud ROBERT, MD         
Principal Investigator: Maud ROBERT, MD         
Service de Chirurgie Générale, Digestive et Endocrinienne - Hôpital Nord Recruiting
Marseille, France, 13015
Contact: Olivier EMUNGANIA, MD         
Principal Investigator: Olivier EMUNGANIA, MD         
Service de Chirurgie Digestive et Endocrinienne - Hôtel Dieu Recruiting
Nantes, France, 44000
Contact: Claire BLANCHARD LOUIS, MD         
Principal Investigator: Claire BLANCHARD LOUIS, MD         
Service de Chirurgie Digestive et Transplantation - Hôpital Archet II Recruiting
Nice, France, 06202
Contact: Antonio IANNELLI, MD         
Principal Investigator: Antonio IANNELLI, MD         
Département de Chirurgie Digestive et Hépatobiliaire - Hôpital Pitié Salpétrière Recruiting
Paris, France, 75013
Contact: Adriana TORCIVIA, MD         
Principal Investigator: Adriana TORCIVIA, MD         
Département de Chirurgie Digestive - Institut Mutualiste Montsouris Recruiting
Paris, France, 75014
Contact: Guillaume POURCHER, MD         
Principal Investigator: Guillaume POURCHER, MD         
Service de Chirurgie Digestive - Hôpital Bichat Recruiting
Paris, France, 75018
Contact: Simon MSIKA, MD         
Principal Investigator: Simon MSIKA, MD         
Service de Chirurgie Digestive, Générale et Cancérologique - HEGP Recruiting
Paris, France, 75908
Contact: Tigran POGHOSYAN, MD         
Principal Investigator: Tigran POGHOSYAN, MD         
Service d'Endocrinologie, Diabète et Nutrition - Centre Hospitalier Lyon Sud - HCL Recruiting
Pierre-Bénite, France, 69495
Contact: Emmanuel DISSE, MD         
Principal Investigator: Emmanuel DISSE, MD         
Département de Chirurgie Digestive et Hépatobiliaire - Centre Hospitalier Privé Saint Grégoire Recruiting
Saint-Grégoire, France, 35760
Contact: Adrien STERKERS, MD         
Principal Investigator: Adrien STERKERS, MD         
Service de Chirurgie Générale et Digestive - Hôpital Purpan Recruiting
Toulouse, France, 31059
Contact: Maël CHALRET DURIEU, MD         
Principal Investigator: Maël CHALRET DURIEU, MD         
Service de Chirurgie Digestive, Hépatobiliaire et Endocrinienne - Hôpital Brabois adultes Recruiting
Vandœuvre-lès-Nancy, France, 54511
Contact: Laurent BRUNAUD, MD         
Principal Investigator: Laurent BRUNAUD, MD         
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03610256     History of Changes
Other Study ID Numbers: 69HCL18_0042
2018-A01051-54 ( Other Identifier: ID-RCB )
First Posted: August 1, 2018    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
Obesity
Bariatric surgery
Single-anastomosis duodeno ileal bypass (SADI)
Roux-en-Y Gastric Bypass

Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms