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Complications After Bariatric Surgery Based, a Questionnaire Survey

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ClinicalTrials.gov Identifier: NCT01930851
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : December 5, 2014
Sponsor:
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 questionnaire survey of complications such as pain, dumping and hypoglycemia after RYGB. Moreover we will the quality of life after RYGB operation. We will invite 3500 RYGB operated patients the Central Denmark Region who have been operated 2006-2011.


Condition or disease Intervention/treatment
Complications After Gastric Bypass Operation Procedure: Gastric bypass operation

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 1429 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prevalence of Medical and Nutritional Complications After Bariatric Surgery (Gastric Bypass) Based on a Questionnaire Survey
Study Start Date : February 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Gastric bypass
All gastric bypass operated patients in the Central Denmark Region 2006-2011
Procedure: Gastric bypass operation



Primary Outcome Measures :
  1. Quality of life [ Time Frame: 2-7 years ]

Secondary Outcome Measures :
  1. Selfreported complications [ 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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Gatric bypass operated patients in the Central Denmark Region
Criteria

Inclusion Criteria:

  • gastric bypass operation 206-2011
  • Residents i the Central 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 ClinicalTrials.gov identifier (NCT number): NCT01930851


Locations
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Denmark
department of endocrinology and metabolism, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
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Study Director: Bjørn Richelsen, Professor, DMSc Aarhus University Hospital

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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01930851    
Other Study ID Numbers: 1-16-02-139-13
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
Quality of life
Complications