Effects of Long Biliopancreatic Limb Versus Long Alimentary Limb in Superobesity, a Randomized Study

Effects of Long Biliopancreatic Limb vs Long Alimentary Limb in Superobesity

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02033577

Acronym

BMI>50

Enrollment

200

Registered

2014-01-13

Start date

2011-08-31

Completion date

2016-08-31

Last updated

2015-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Obesity

Brief summary

Surgical bypassing of a longer section of the small bowel (when doing a gastric bypass operation) gives better results on body weight in the superobese. We do not yet know whether it is beneficial to exclude more of the proximal small bowel or more of the distal. Side effects of bypassing can also be different. Study aims at clarifying possible differences in effects and side-effects of these two surgical-technical variations.

Detailed description

Randomisation in the OR between long biliopancreatic limb and long alimentary limb. GAstric component identical. Perioperative biopsies to assess mucosal properties at the gastrojejunostomy and the enteroanastomosis. Repeat biopsies (gastroscopy) at one year to identify changes in the mucosa at the Gastroenteroanastomosis.

Interventions

PROCEDUREDistal gastrojejunal bypass

RYGB with 200 cm BP limb and 150 cm common limb, effect on EWL, QoL and complications

PROCEDURERYGB

RYGB with 60 cm BP limb and 150 cm alimentary limb, effect on

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* BMI \> 50

Exclusion criteria

* Psychiatric disease * Inflammatory bowel disease * inability to understand Swedish

Design outcomes

Primary

Measure	Time frame	Description
Body weight reduction	2 years from end of inclusion	Body weight reduction is currently the best substitute endpoint to correlate with the hard endpopints such as death, comorbidities etc.

Secondary

Measure	Time frame	Description
Patient assessed quality of life	2 years from end of inclusion	We employ SF-36, Op-9, GSRS, TFEQ scales

Other

Measure	Time frame	Description
Short-term complications	0-30 days postoperatively	Time to discharge, leaks, bleeding

Countries

Sweden

Contacts

Primary ContactJan Hedenbro, MD,PhD

jan.hedenbro@aleris.se+46705132572

Backup ContactHjortur G Gislason, MD,PhD

hjortur.gislason@aleris.no+4748891375

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026