Different Limb Lengths in Gastric Bypass Surgery (SLIM)

• ClinicalTrials.gov Identifier: NCT04219787
• Recruitment Status: Active, not recruiting
• First Posted: January 7, 2020
• Last Update Posted: November 13, 2023
• Sponsor: Clarunis - Universitäres Bauchzentrum Basel
• Information provided by (Responsible Party): Clarunis - Universitäres Bauchzentrum Basel

Tracking Information

• First Submitted Date: January 3, 2020
• First Posted Date: January 7, 2020
• Last Update Posted Date: November 13, 2023
• Actual Study Start Date: June 1, 2020
• Estimated Primary Completion Date: November 30, 2028 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 9, 2023)

Primary endpoint [ Time Frame: From baseline to 5 years after surgery. ]

Percent total weight loss (%TWL, superiority), while not leading to a larger nutritional de- ficiency rate (non-inferiority).

Original Primary Outcome Measures (submitted: January 4, 2020)

Excess BMI loss (%EBMIL) [ Time Frame: From baseline to 5 years after surgery. ]

The change of percent excess BMI loss (%EBMIL) after surgery.

Current Secondary Outcome Measures (submitted: November 9, 2023)

Secondary endpoints [ Time Frame: From baseline to 5 years after surgery. ]

Percent excess body mass index loss (%EBMIL), remission of comorbidities, complication rate/safety, and quality of life 1, 3, and 5 years after long and short BPL RYGB.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Different Limb Lengths in Gastric Bypass Surgery
• Official Title: Swiss Multicenter Randomized Controlled Trial on Different Limb Lengths in Gastric Bypass Surgery
• Brief Summary: Obesity and type 2 diabetes mellitus (T2DM) are reaching epidemic proportions in the developed world. In morbidly obese patients only surgical treatment (bariatric operations) leads to a sustained weight loss and relief of co-morbidities in the majority of patients. One of the most frequently performed operations is the laparoscopic proximal Roux-en-Y gastric bypass (LRYGB). There is still lack of knowledge why some patients respond much better than others to an identically performed procedure. Therefore, a number of variations of this operation have been introduced over the past 50 years. Increasing the length of small bowel being bypassed has the potential to improve the effect of the operation but buries the risk of nutrient deficiencies. The metabolic effect of LRYGB occurs, in part, independently of weight loss. The mechanisms underlying metabolic improvement through metabolic surgery are not yet fully understood.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Obesity, Morbid
• Diabetes Mellitus, Type 2
• Hypertension
• Dyslipidemias
• Sleep Apnea

Intervention

• Procedure: Long BPL LRYGB
  LRYGB with an 180 cm BPL and an AL of 80 cm.
  Other Name: LBPL LRYGB
• Procedure: Short BPL LRYGB
  The second group will receive a standard LRYGB with a 80 cm BPL and a 180 cm long AL.
  Other Name: SBPL LRYGB

Study Arms

• Experimental: Long Biliopancreatic Limb LRYGB
  LRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm.
  Intervention: Procedure: Long BPL LRYGB
• Active Comparator: Short Biliopancreatic Limb LRYGB
  Standard LRYGB with a 80 cm BPL and a 180 cm long AL.
  Intervention: Procedure: Short BPL LRYGB

• Publications *: Kraljevic M, Schneider R, Wolnerhanssen B, Bueter M, Delko T, Peterli R. Different limb lengths in gastric bypass surgery: study protocol for a Swiss multicenter randomized controlled trial (SLIM). Trials. 2021 May 19;22(1):352. doi: 10.1186/s13063-021-05313-6.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: January 4, 2020): 800
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 30, 2028
• Estimated Primary Completion Date: November 30, 2028 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• informed consent as documented by signature
• patients with BMI of 35 kg/m2 or higher who comply with the regulatory rules for bariatric surgery in Switzerland

Exclusion Criteria:

• general contraindications to kind of surgery
• known or suspected non-compliance, drug or alcohol abuse
• inability to follow the procedures of the study, e.g. due to language problems, psychological disorders etc. of the participant
• participation in another study
• age < 18 years or > 65 years
• BMI > 60 kg/m2
• height < 145 cm
• CL length of < 180 cm as measured intraoperatively
• ASA physical status classification > III
• inflammatory bowel disease

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT04219787
• Other Study ID Numbers: 2019-02392
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Clarunis - Universitäres Bauchzentrum Basel
• Original Responsible Party: Same as current
• Current Study Sponsor: Clarunis - Universitäres Bauchzentrum Basel
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Marko Kraljevic, MD; Clarunis - Universitäres Bauchzentrum Basel
• Study Chair: Marco Bueter, MD, Professor; University Hospital Zurch

• PRS Account: Clarunis - Universitäres Bauchzentrum Basel
• Verification Date: November 2023