Role and Mechanisms of Obesity Surgery

Obesity Clinical Trial

— RAMOSPHYSSURG  

Official title:

Role and Mechanisms of Obesity Surgery - Physical Activity and Other Predictors of Hospital Stay, Recovery and Complications After Obesity Surgery

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01998815
• Other study ID #: Dnr 310-13
• Status: Suspended
• 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
• 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

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity
• Physical Activity
• Post-operative Complications
• Postoperative Complications
• Quality of Life

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

External Links

•   Scandinavian Surgical Outcomes Research Group homepage