Outcomes of Mini-Gastric Bypass with Various Biliopancreatic Limb Lengths

Outcomes of Mini-Gastric Bypass with Various Biliopancreatic Limb Lengths: a Retrospective Single-Center Cohort Study in the Netherlands

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON26318

Enrollment

737

Registered

2020-06-03

Start date

2020-06-03

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Morbid obesity

Interventions

None

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria - Treatment at the Center Obesity North-Netherlands - Mini-gastric bypass between January 2015 and December 2016 - According the international IFSO guidelines: o BMI = 40 kg/m² or o BMI = 35 kg/m² with obesity-associated disease: diabetes mellitus type 2, sleep apnea, hypertension, arthrosis, cardiovascular disease, or asthma/COPD. - Age between 18 and 65 years

Exclusion criteria

Exclusion criteria: Exclusion criteria - Previous bariatric procedures (band or gastric sleeve)

Design outcomes

Primary

Measure	Time frame
Primary endpoint The primary objective of this study is to determine the total weight loss (% TWL) at 3 years Definition: TWL = ([initial weight – attained weight]/ initial weight) x 100	—

Secondary

Measure	Time frame
Secondary endpoints - The percentage of total weight loss (%TWL) at 1, 2, 4 and 5 years - The percentage of excess weight loss (%EWL) at 1, 2, 3, 4 and 5 years Definition EWL = (initial weight – postoperative weight) / (initial weight – ideal weight) - The percentage excess BMI loss at 1,2, 3, 4 and 5 years Definition excess BMI loss = (? BMI/ (initial BMI -25)) x 100 - Average BMI and distribution of BMI achieved after 1, 2, 3, 4 and 5 years - Number of patients with total, partial or no remission of hypertension, defined by the changes in dose of anti-hypertensive medication - Number of patients with total, partial or no remission of diabetes mellitus type 2, defined by the changes in dose of diabetes medication - To compare the outcomes of the above parameters in the subgroups with different lengths of the BP-limb - Number of patients with symptoms of biliary reflux after MGB, defined by treatment with medication (antacids, proton pump inhibitor or sucralfate) or a conversion to RYGB due biliary reflux - Identify specific predictors for the outcomes of the MGB (co-morbitities, body length as surrogate for total small bowel length)	—

Measure

Time frame

Secondary endpoints - The percentage of total weight loss (%TWL) at 1, 2, 4 and 5 years - The percentage of excess weight loss (%EWL) at 1, 2, 3, 4 and 5 years Definition EWL = (initial weight – postoperative weight) / (initial weight – ideal weight) - The percentage excess BMI loss at 1,2, 3, 4 and 5 years Definition excess BMI loss = (? BMI/ (initial BMI -25)) x 100 - Average BMI and distribution of BMI achieved after 1, 2, 3, 4 and 5 years - Number of patients with total, partial or no remission of hypertension, defined by the changes in dose of anti-hypertensive medication - Number of patients with total, partial or no remission of diabetes mellitus type 2, defined by the changes in dose of diabetes medication - To compare the outcomes of the above parameters in the subgroups with different lengths of the BP-limb - Number of patients with symptoms of biliary reflux after MGB, defined by treatment with medication (antacids, proton pump inhibitor or sucralfate) or a conversion to RYGB due biliary reflux - Identify specific predictors for the outcomes of the MGB (co-morbitities, body length as surrogate for total small bowel length)

—

Contacts

Public ContactNienke Slagter

Medisch Centrum Leeuwarden

nienke.slagter@znb.nl0582863859

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)