Overview

This trial is active, not recruiting.

Conditions obesity, bariatric surgery, physical activity, post-operative complications, quality of life
Treatment laparoscopic roux-en-y gastric bypass surgery
Sponsor Göteborg University
Start date March 2015
End date December 2016
Trial size 40 participants
Trial identifier NCT01998815, Dnr 310-13

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Laparoscopic Roux-en-Y gastric bypass
laparoscopic roux-en-y gastric bypass surgery

Primary Outcomes

Measure
Post-operative recovery and complications
time frame: 30 days

Secondary Outcomes

Measure
Post-operative well-being and late complications
time frame: 24 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - >18 y of age - BMI >35 Exclusion Criteria: - non-knowledgeable in Swedish language

Additional Information

Official title Role and Mechanisms of Obesity Surgery - Physical Activity and Other Predictors of Hospital Stay, Recovery and Complications After Obesity Surgery
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Göteborg University.