Prevalence of Complications After Bariatric Surgery - an Epidemiologic Survey

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:

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
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Surgical complications [ Time Frame: 2-7 years ]
    Ileus, pain, infections, kidney stones

Secondary Outcome Measures :
  1. Use of drugs before and after bariatric surgery [ Time Frame: 2-7 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients WHO have had bariatric surgery in the Central and North Denmark Region 2006-2011

Inclusion Criteria:

  • Bariatric surgery 2006-2011
  • resident in the Central and North Denmark Region

Exclusion Criteria:

Information from the National Library of Medicine

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 identifier (NCT number): NCT01930929

Contact: Sigrid Bjerge Gribsholt, MD +4561651148

Department of Endocrinology and Internal Medicine Recruiting
Aarhus, Denmark, 8000
Contact: Sigrid Gribsholt, MD         
Sponsors and Collaborators
University of Aarhus
Study Director: Bjorn Richelsen, Professor, DMSc Department of Medicine and Endocrinology, Aarhus University Hospital

Responsible Party: University of Aarhus Identifier: NCT01930929     History of Changes
Other Study ID Numbers: 1-16-02-153-13
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: August 2013

Keywords provided by University of Aarhus:
Bariatric surgery