Prevalence of Complications After Bariatric Surgery - an Epidemiologic Survey

NCT01930929 | Completed

• 1 other identifier: 1-16-02-153-13
• Study Type: observational
• Target: 9,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Complications After Bariatric Surgery

Keywords

Bariatric surgery; Complications; Drugs

Outcome Measures

Primary Outcomes (1)

• Surgical complications

  Ileus, pain, infections, kidney stones

  2-7 years

Secondary Outcomes (1)

• Use of drugs before and after bariatric surgery

  2-7 years

Study Arms (1)

Bariatric surgery operated patients

All patients who have operated in the Central and North Denmark Region 2006-2011

Procedure: Bariatric surgery

Interventions

Bariatric surgery PROCEDURE

Also known as: All patients with a primary gastric bypass operation

Bariatric surgery operated patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients WHO have had bariatric surgery in the Central and North Denmark Region 2006-2011

You may qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Department of Endocrinology and Internal Medicine

Aarhus, 8000, Denmark

Location

MeSH Terms

Interventions

Bariatric Surgery

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Bjorn Richelsen, Professor, DMSc

  Department of Medicine and Endocrinology, Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2013
• First Posted: August 29, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 4, 2020

Record last verified: 2015-12

Locations

DK (1)