NCT04219787

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jun 2020Nov 2028

First Submitted

Initial submission to the registry

January 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

8.5 years

First QC Date

January 3, 2020

Last Update Submit

November 9, 2023

Conditions

Obesity, MorbidDiabetes Mellitus, Type 2HypertensionDyslipidemiasSleep Apnea

Keywords

Roux-en-Y Gastric BypassBiliopancreatic Limb Length

Outcome Measures

Primary Outcomes (1)

  • Primary endpoint

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

    From baseline to 5 years after surgery.

Secondary Outcomes (1)

  • Secondary endpoints

    From baseline to 5 years after surgery.

Study Arms (2)

Long Biliopancreatic Limb LRYGB

EXPERIMENTAL

LRYGB with an 180 cm biliopancreatic limb (BPL) and an alimentary limb (AL) of 80 cm.

Procedure: Long BPL LRYGB

Short Biliopancreatic Limb LRYGB

ACTIVE COMPARATOR

Standard LRYGB with a 80 cm BPL and a 180 cm long AL.

Procedure: Short BPL LRYGB

Interventions

Long BPL LRYGBPROCEDURE

LRYGB with an 180 cm BPL and an AL of 80 cm.

Also known as: LBPL LRYGB
Long Biliopancreatic Limb LRYGB
Short BPL LRYGBPROCEDURE

The second group will receive a standard LRYGB with a 80 cm BPL and a 180 cm long AL.

Also known as: SBPL LRYGB
Short Biliopancreatic Limb LRYGB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clarunis University Center for Gastrointestinal and Liver Diseases

Basel, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 34011386DERIVED

MeSH Terms

Conditions

Obesity, MorbidDiabetes Mellitus, Type 2HypertensionDyslipidemiasSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Marko Kraljevic, MD

    Clarunis - Universitäres Bauchzentrum Basel

    STUDY CHAIR

  • Marco Bueter, MD, Professor

    University Hospital Zurch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2020

First Posted

January 7, 2020

Study Start

June 1, 2020

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)