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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT01998815
Other study ID # Dnr 310-13
Secondary ID
Status Suspended
Phase
First received
Last updated
Start date March 1, 2015
Est. completion date December 31, 2022

Study information

Verified date November 2021
Source Göteborg University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 40
Est. completion date December 31, 2022
Est. primary completion date December 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - >18 y of age - BMI >35 Exclusion Criteria: - non-knowledgeable in Swedish language

Study Design


Intervention

Procedure:
Laparoscopic Roux-en-Y gastric bypass surgery


Locations

Country Name City State
Sweden Sahglrenska University Hospital Gothenburg

Sponsors (1)

Lead Sponsor Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post-operative recovery and complications 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). 30 days
Secondary Post-operative well-being and late complications 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). 24 months
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