Role and Mechanisms of Obesity Surgery

Suspended

• Conditions: Bariatric Surgery; Quality of Life; Obesity; Physical Activity; Post-operative Complications
• Interventions: Procedure: Laparoscopic Roux-en-Y gastric bypass surgery

• Registration Number: NCT01998815
• Lead Sponsor: Göteborg University

Brief Summary

The purpose of this study is to examine how physical activity and lifestyle factors influence postoperative recovery and postoperative complications after bariatric surgery.

The hypothesis is that physically active people, with a healthy alcohol consumption and non smokers have shorter lengths of hospital stay, shorter sick-leave, fewer re-hospitalizations and fewer re-operations, fewer complications as well as a faster recovery after a surgical procedure.

The investigators also hypothesize that possible risk factors for non-surgical postoperative complications e g abdominal discomfort are also life-style related factors such as smoking, high alcohol consumption, low level of physical activity, as well as other risk factors such as prior frequent abdominal pains (e g irritable bowel syndrome symptoms), high levels of anxiety and/or depression, difficulties with coping with the changed food intake regimen after obesity surgery, and generally high sensitivity for painful-sensations and nausea.

First aim of this study is to investigate how life style factors prior to obesity surgery are related to hospital stay, sick-leave, immediate postoperative complication rates and the rate of resumption of QoL and normal physical function.

The second aim of the study is to identify risk factors for the development of chronic abdominal discomfort and dumping symptoms after obesity surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-25
• Study First Submitted QC: 2013-11-29
• Study First Posted: 2013-12-02
• Study Start: 2015-03-01
• Primary Completion: 2017-12-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-29
• Last Update Posted: 2021-12-10
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• >18 y of age
• BMI >35

Exclusion Criteria

• non-knowledgeable in Swedish language

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese patients	Laparoscopic Roux-en-Y gastric bypass surgery	Laparoscopic Roux-en-Y gastric bypass

Primary Outcome Measures

Name	Time	Method
Post-operative recovery and complications	30 days	Length of hospital stay, post-operative sick-leave, rate of post-operative complications; bleeding, anastomotic leakage, re-admission, re-operation, thromboembolic complications (deep-venous thrombosis, pulmonary embolism).

Secondary Outcome Measures

Name	Time	Method
Post-operative well-being and late complications	24 months	Post-operative well-being and late complications such as persistent gastrointestinal adverse symptoms abdominal discomfort, pain (measured using gastrointestinal symptom rating scale ;GSRS), dumping syndrome (measured by dumping syndrome rating scale), quality of life (SF-36 and EQ5d), physical activity level (Saltin Grimby), depression and anxiety rating (Hospital Depression and Anxiety rating scale), pain anxiety (Pain Catastrophizing scale).

Trial Locations

Locations (1)

Sahglrenska University Hospital; 🇸🇪 Gothenburg, Sweden