Different Limb Lengths in Gastric Bypass Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2028-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Long Biliopancreatic Limb LRYGB

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

Group Type EXPERIMENTAL

Long BPL LRYGB

Intervention Type PROCEDURE

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

Short Biliopancreatic Limb LRYGB

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

Group Type ACTIVE_COMPARATOR

Short BPL LRYGB

Intervention Type PROCEDURE

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

Interventions

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Long BPL LRYGB

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

Intervention Type PROCEDURE

Short BPL LRYGB

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

Intervention Type PROCEDURE

Other Intervention Names

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LBPL LRYGB SBPL LRYGB

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No