Role and Mechanisms of Obesity Surgery

NCT ID: NCT01998815

Last Updated: 2021-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-01

Study Completion Date

2022-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Obese patients

Laparoscopic Roux-en-Y gastric bypass

Laparoscopic Roux-en-Y gastric bypass surgery

Intervention Type PROCEDURE

Interventions

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Laparoscopic Roux-en-Y gastric bypass surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* \>18 y of age
* BMI \>35

Exclusion Criteria

* non-knowledgeable in Swedish language
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sahglrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Dnr 310-13

Identifier Type: -

Identifier Source: org_study_id