Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery

Obesity Clinical Trial

Official title:

Management of Sleeve Gastrectomy Failure Using Single-anastomosis Metabolic Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05242835
• Other study ID #: Second stage SADI
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: March 2027

Study information

• Verified date: February 2022
• Source: Laval University
• Contact: Mélanie Nadeau, MSc
• Phone: 418-656-8711
• Email: melanie.nadeau[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sleeve gastrectomy (SG) has become the most commonly performed weight loss surgery, accounting for 60% of all bariatric operations worldwide. While technically easier with less side-effects and nutritional risks than other operations, SG is also associated with a higher risk of failure (20 to 40%). In such case, the most effective option consists in adding an intestinal bypass called the Biliopancreatic Diversion with Duodenal Switch (BPD-DS). This surgery is, however, technically challenging and yields a significant risk of complications, nutritional deficiencies or gastro-intestinal side-effects. Recently, a simplified version of the Standard DS, called Single-Anastomosis Duodenoileal Switch (SADI-S) was endorsed by surgical societies as one of the approved bariatric procedures. There is currently no prospective or randomized data to support the effectiveness of this new procedure, especially as a revisional approach. The Overall Objective of this randomized controlled trial project is to establish the clinical benefits of the SADI-S as a revisional surgery after SG, while also considering critical issues related to sex and gender. The investigator Overall Hypothesis is that the SADI-S represents a relevant revisional option for weight loss and metabolic recovery in women and men suffering from severe obesity who had a previous SG. The investigator propose to address the following research question.

Research Question: What are the clinical effects of SADI-S compared to standard DS when used as a revisional procedure after SG, in patients with obesity? Participants who need revisional surgery after SG will be enrolled in a prospective, randomized, double-blind (patient-evaluator), non-inferiority trial comparing SADI-S vs DS. The primary outcome will be 12-month excess weight loss. Secondary outcomes will be perioperative complications, risk of malnutrition, quality of life and gastrointestinal side effects. The investigator hypothesize that SADI-S offers similar weight loss compared to standard DS, but a lower risk of complications and nutritional deficiencies.

With the increase in the number of bariatric operations performed worldwide and the recent endorsement of the SADI-S as a regular procedure, reliable clinical data are urgently needed. The present proposal will directly address this knowledge gap.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 151
• Est. completion date: March 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• had sleeve gastrectomy a minimum of 18 months before

• still meet the NIH criteria for bariatric surgery (BMI=35kg/m2 with major comorbidities or BMI=40kg/m2) or patients with EWL<50% or significant weight regain (=20%EWL)

Exclusion Criteria:

• general contra-indication for bariatric surgery

• BMI<35kg/m2

• pregnancy

• cirrhosis

• abnormal bowel habits including irritable bowel syndrome and inflammatory bowel disease

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Standard duodenal switch
Standard duodenal switch as second stage surgery after a sleeve gastrectomy (100cm common channel and 150cm alimentary limb)
• Single-anastomosis duodenal switch
Single-anastomosis duodeno-ileal anastomosis as second stage surgery after a sleeve gastrectomy (250cm common channel)

Locations

Country	Name	City	State
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec City	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Institut universitaire de cardiologie et de pneumologie de Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excess weight loss	Percentage of excess weight loss mobilized in response to surgery	12 month
Secondary	Peroperative complications	Complications graded with Clavien classification	from baseline up to 60 months
Secondary	Risk of malnutrition	Risk of malnutrition assessed through measurement of its risk being mild (albumin<35g\L), moderate (albumin<30g/L) or severe (albumin<25g/L)	from baseline to 60 months
Secondary	Change in quality of life (SF-36)	36-item short form survey evaluating quality of life on a scale form 0 to 100	from baseline to 60 months
Secondary	Change in quality of life (BAROS)	Bariatric Analyses and Reporting Outcomes System score form -7 to 9	from baseline to 60 months
Secondary	Change in quality of life (QLaval)	Laval questionnaire evaluating quality of life on 6 aspects on a scale from 0 to 7	from baseline to 60 months
Secondary	Gastro-intestinal side effects	Evaluation of gastro-intestinal side effects with the Gastro-Intestinal Quality of Life Index from 0 to 144	from baseline to 60 months
Secondary	Change in nutritional status (calcium)	Change in nutritional status based on blood analysis of calcium (mmol/L)	from baseline to 60 months
Secondary	Change in nutritional status (ferritin)	Change in nutritional status based on blood analysis of ferritin (ug/L)	from baseline to 60 months
Secondary	Change in nutritional status (TIBC)	Change in nutritional status based on blood analysis of TIBC (umol/L)	from baseline to 60 months
Secondary	Change in nutritional status (iron)	Change in nutritional status based on blood analysis of iron (umol/L)	from baseline to 60 months
Secondary	Change in nutritional status (prealbumin)	Change in nutritional status based on blood analysis of prealbumin (g/L)	from baseline to 60 months
Secondary	Change in nutritional status (transferrin)	Change in nutritional status based on blood analysis transferrin (g/L)	from baseline to 60 months
Secondary	Change in nutritional status (vitamin A)	Change in nutritional status based on blood analysis of vitamin A (umol/L)	from baseline to 60 months
Secondary	Change in nutritional status (vitamin D3)	Change in nutritional status based on blood analysis of vitamin D3 (nmol/L)	from baseline to 60 months
Secondary	Change in nutritional status (parathormone)	Change in nutritional status based on blood analysis parathormone (ng/L)	from baseline to 60 months
Secondary	Change in food intake	Evaluation of the change in food intake using a web-based food frequency questionnaire (kcal/day)	from baseline to 60 months
Secondary	Change in eating behavior	Change of eating behavior using the Three-Factor Eating Questionnaire evaluating cognitive restraint of eating on a scale from 0 to 20, disinhibition on a scale from 0 to 16 and hunger on a scale from 0 to 15	from baseline to 60 months
Secondary	Change in food addiction	Change of eating behavior using the Yale Food Addiction Scale that includes a "symptom count" scale from 0 to 7 reflecting the number of addiction-like criteria endorsed and a dichotomous evaluation that indicates whether a threshold of three or more "symptoms" plus clinically significant impairment or distress has been met	from baseline to 60 months
Secondary	Change in binge eating behavior	Change of eating behavior using the Binge Eating scale from 0 to 46	from baseline to 60 months
Secondary	Evolution of obesity related diseases	Remission rate for comorbidities, including T2D, hypertension, dyslipidemia, sleep apnea according to the ASMBS definition of outcomes reporting	from baseline to 60 months