Prevalence of Complications After Bariatric Surgery - an Epidemiologic Survey
|ClinicalTrials.gov Identifier: NCT01930929|
Recruitment Status : Unknown
Verified August 2013 by University of Aarhus.
Recruitment status was: Recruiting
First Posted : August 29, 2013
Last Update Posted : December 5, 2014
The number of obese is increasing rapidly. Bariatric surgery is used to a greater and greater extent as treatment of obesity to obtain a greater and more permanent weight loss. The currently most commonly used surgical method is the gastric bypass (RYGB), which so far has proved to be the most effective way to achieve a greater and more permanent weight loss, reduction and maybe even elimination of many of the obesity-related health complication (diabetes, sleep apnea, pain due to osteoarthrosis etc.).
Bariatric surgery, including RYGB is also associated with medical and nutritional complications. This will be a natural consequence of the fact that the food bypasses virtually the entire ventricle and 100-150 cm of the upper part of the small intestine after a RYGB. Therefore, problems with uptake of for example B12, iron, folate, thiamin, fat-soluble vitamins (Vitamins A, D, E and K) copper, zinc and selenium are expected. In the light of this, it is decided that all RYGB operated patients must take vitamin B12, iron and vitamin D substitution. In spite of this, many develop various nutritional problems after RYGB. In addition to these nutritional complications are complications such as hypoglycaemia and gallstone attacks after RYGB.
Nevertheless there is no comprehensive inventory of the occurrence of nutritional complications after bariatric surgery neither in Denmark nor in an international context. Thus there is no consensus on an optimal postoperative prevention of complications. An overview of the occurrence of these problems will be important for assessing and determine the indications for bariatric surgery as well as to optimize the prevention of complications.
To enlighten this we will conduct a cohort study of complications by investigating hospitalizations and deaths after RYGB. Moreover we will get an overview on medication use before and after RYGB operation in the Central Denmark Region and in the North Denmark Region 2006-2011 (about 5000 patients).
|Condition or disease||Intervention/treatment|
|Complications After Bariatric Surgery||Procedure: Bariatric surgery|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||Prevalence of Medical and Nutritional Complications After Bariatric Surgery (Gastric Bypass) Based on an Epidemiologic Survey|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||July 2016|
Bariatric surgery operated patients
All patients who have operated in the Central and North Denmark Region 2006-2011
Procedure: Bariatric surgery
Other Name: All patients with a primary gastric bypass operation
- Surgical complications [ Time Frame: 2-7 years ]Ileus, pain, infections, kidney stones
- Use of drugs before and after bariatric surgery [ Time Frame: 2-7 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930929
|Contact: Sigrid Bjerge Gribsholt, MDfirstname.lastname@example.org|
|Department of Endocrinology and Internal Medicine||Recruiting|
|Aarhus, Denmark, 8000|
|Contact: Sigrid Gribsholt, MD|
|Study Director:||Bjorn Richelsen, Professor, DMSc||Department of Medicine and Endocrinology, Aarhus University Hospital|