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ID
Source
Brief title
Health condition
Morbid obesity
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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 = (Δ 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)
Background summary
Bariatric surgery is the most effective therapy for obesity, leading to a sustained weight loss, remission of co-morbidities, and a decreased mortality. In 1997 Rutledge introduced the mini-gastric bypass (MGB). This entails a gastrojejunal anastomosis between a long gastric pouch and a jejunal omega loop. Previous studies demonstrated the MGB to be a safe procedure with low mortality and morbidity. The limiting step to broaden the utilization of MGB, is the lack of standardization. Currently, there is no standard guideline for the optimal biliopancreatic (BP) limb length. Technical variations limit the comparability of the currently literature and therefore hinder the obtaining of a consensus on the best way to determine the BP-limb length.
This is a single center retrospective cohort study. From January 2015 to December 2016, all patients who underwent a mini-gastric bypass at the Center Obesity North-Netherlands were included in a prospective database and will be retrospectively analyzed. The follow-up information will be included up to 5 years after the initial surgery. The aim of this study is to describe the MGB procedure as performed in our center and to assess both efficacy and safety of this technique. Furthermore, the aim is to investigate the impact of various BP-limb lengths in terms of weight loss and resolution of co-morbidities.
Study objective
The purpose of the study is to evaluate the outcomes and midterm follow-up in the mini-gastric bypass in terms of weight loss, resolution of co-morbidities and the impact of different BP-limb lengths.
Study design
Day of the surgery and follow-up visit 1 (10-14 months), 2 (18-30 months), 3 (30-42 months), 4 (42-54 months) and 5 (54-66 months) years after surgery.
Intervention
None
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
- Previous bariatric procedures (band or gastric sleeve)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8704 |
| Other | RTPO Leeuwarden approved as non-WMO study : RTPO 2020 0036 |