Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery

Postoperative Complications Clinical Trial

Official title:

Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862159
• Other study ID #: EPN 2012/039
• Status: Completed
• Phase: N/A
• First received: May 2, 2013
• Last updated: October 13, 2016
• Start date: May 2007
• Est. completion date: May 2013

Study information

• Verified date: October 2016
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review BoardSweden: Swedish Data Inspection BoardSweden: The National Board of Health and Welfare
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The rate of serious complications are relatively low in bariatric surgery today, but still 3-4 % will suffer from a serious complication. There are factors known before the surgery or during the operation that are likely to increase the risk for a serious complication. If the investigators are aware of these we can optimize the patients risk factors prior to the operation or at least increase the awareness of the increased risk in some patients given the presence of risk factors.

Description:

Data is collected prospectively to the Scandinavian Obesity Surgery Registry. Today all 44 clinics performing bariatric surgery in Sweden submits data on baseline characteristics, operational data and data from a 30 days, 1 year, 2 years and 5 years follow up for all patients. The database is compared annually to the Swedish civil registry to cover all mortality.

From the database we will identify patients who underwent a bariatric procedure between May 1st 2007 and September 30th 2012. Patients undergoing other bariatric procedures than laparoscopic gastric bypass or revisional surgery will be excluded.

The data will be analyzed with "Chi-2" test, logarithmic regression, linear regression or t-test when appropriate. Odds ratio will be calculated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25038
• Est. completion date: May 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

Undergoing laparoscopic gastric bypass surgery and included in the Scandinavian Obesity Surgery Registry

Exclusion Criteria:

Undergoing other bariatric procedure than laparoscopic gastric bypass. Revisional surgery is excluded.

Lost to follow up.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Postoperative Complications

Intervention

Procedure:
• laparoscopic gastric bypass surgery
laparoscopic gastric bypass surgery

Locations

Country	Name	City	State
Sweden	University Hospital Örebro	Örebro

Sponsors (2)

Lead Sponsor	Collaborator
Region Örebro County	Scandinavian Obesity Surgery Registry

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serious complications	Graded as Clavien 3b or more (for patients entered in the registry after January 1st 2010)	30 days or the postoperative hospital stay if longer than 30 days	Yes
Secondary	Operating time	length of the operation	operation	No
Secondary	Length of stay	Length of stay after the primary operation	30 days or the postoperative hospital stay if longer than 30 days	No
Secondary	Specific postoperative complications	Anastomotic leakage/abscesses, bleeding, small bowel obstruction, stomal ulcera, cardiovascular complications, pulmonary complications, venous thromboembolism	30 days or the postoperative hospital stay if longer than 30 days	Yes

External Links

•   The Scandinavian Obesity Surgery Registry