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Prevalence of Complications After Bariatric Surgery - an Epidemiologic Survey

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01930929
First received: August 19, 2013
Last updated: September 30, 2013
Last verified: August 2013
  Purpose

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 Intervention
Complications After Bariatric Surgery
Procedure: Bariatric surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prevalence of Medical and Nutritional Complications After Bariatric Surgery (Gastric Bypass) Based on an Epidemiologic Survey

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Surgical complications [ Time Frame: 2-7 years ] [ Designated as safety issue: No ]
    Ileus, pain, infections, kidney stones


Secondary Outcome Measures:
  • Use of drugs before and after bariatric surgery [ Time Frame: 2-7 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 5000
Study Start Date: November 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01930929

Contacts
Contact: Sigrid Bjerge Gribsholt, MD +4561651148 sigrgrib@rm.dk

Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Bjorn Richelsen, Professor, DMSc Department of Medicine and Endocrinology, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01930929     History of Changes
Other Study ID Numbers: 1-16-02-153-13
Study First Received: August 19, 2013
Last Updated: September 30, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Bariatric surgery
Complications
Drugs

ClinicalTrials.gov processed this record on November 27, 2014