Complications After Bariatric Surgery - a Clinical Trial
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|ClinicalTrials.gov Identifier: NCT01930838|
Recruitment Status : Unknown
Verified September 2013 by University of Aarhus.
Recruitment status was: Not yet 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 the investigators will conduct a clinical trial concerning complications after RYGB. The investigators will examine 350 RYGB operated patients the Central Denmark Region. From a medical interview, blood tests, Dual energy X-ray absorptiometry etc. it will be possible to give a good estimate of the incidence of medical complications. The investigators will explore complications such as: anemia, hypoglycemia, peripheral nerve problems (especially neuropathies), vitamin D / osteoporosis and other mineral / vitamin deficiencies that may be identified through blood tests. A control group of 30-40 age, sex and body mass index matched individuals will go through the same examinations.
|Condition or disease||Intervention/treatment|
|Complications After Gastric Bypass Operation||Procedure: Gastric bypass operation|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||400 participants|
|Observational Model:||Case Control|
|Target Follow-Up Duration:||1 Month|
|Official Title:||Prevalence of Medical and Nutritional Complications After Bariatric Surgery (Gastric Bypass) Based on a Clinical Trial|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||August 2016|
|Estimated Study Completion Date :||December 2016|
Matched on age, sex and body mass index
Gastric bypass operation
Patients with gastric bypass operation between 2006 and 2011 in The Central Denmark Region
Procedure: Gastric bypass operation
- Number of participants with complications [ Time Frame: 2-7 years ]By clinical examinations, blood tests, Dual energy X-ray absorptiometry and urine will be performed
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930838
|Contact: Sigrid Bjerge Gribsholt, MDemail@example.com|
|Contact: Joan Bach Nielsen, MDfirstname.lastname@example.org|
|Study Chair:||Bjørn Richelsen, Professor, DMSc||Aarhus University Hospital|