Role and Mechanisms of Obesity Surgery

NCT01998815 | Suspended DMC

• 1 other identifier: Dnr 310-13
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post-operative well-being and late complications

  24 months

Study Arms (1)

Obese patients

Laparoscopic Roux-en-Y gastric bypass

Procedure: Laparoscopic Roux-en-Y gastric bypass surgery

Interventions

Laparoscopic Roux-en-Y gastric bypass surgery PROCEDURE

Obese patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All obese patients undergoing laparoscopic Roux-en-Y gastric bypass surgery at Sahlgrenska University Hospital in Gothenburg and Kärnssjukhuset in Skövde, Sweden.

You may qualify if:

• \>18 y of age
• BMI \>35

You may not qualify if:

• non-knowledgeable in Swedish language

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Sahglrenska University Hospital

Gothenburg, S41345, Sweden

Location

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 2, 2013
• Study Start: March 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 31, 2022
• Last Updated: December 10, 2021

Record last verified: 2021-11

Locations

SE (1)