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.
ID
Bron
Verkorte titel
Aandoening
Morbid obesity
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
None
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Exclusion criteria
- Previous bariatric procedures (band or gastric sleeve)
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL8704 |
Ander register | RTPO Leeuwarden approved as non-WMO study : RTPO 2020 0036 |