Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery

Completed

• Conditions: Postoperative Complications
• Interventions: Procedure: laparoscopic gastric bypass surgery

• Registration Number: NCT01862159
• Lead Sponsor: Region Örebro County

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2012-11
• Study Completion: 2013-05
• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-23
• Study First Posted: 2013-05-24
• Status Verified: 2017-04
• Results First Submitted: 2017-04-30
• Results First Submitted QC: 2017-04-30
• Last Update Submitted: 2017-04-30
• Results First Posted: 2017-08-11
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25038

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Operated patients	laparoscopic gastric bypass surgery	Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012

Primary Outcome Measures

Name	Time	Method
Serious Complications	30 days or the postoperative hospital stay if longer than 30 days	Graded as Clavien 3b or more (for patients entered in the registry after January 1st 2010)

Secondary Outcome Measures

Name	Time	Method
Operating Time	operation	length of the operation
Length of Stay	30 days or the postoperative hospital stay if longer than 30 days	Length of stay after the primary operation
Specific Postoperative Complications	30 days or the postoperative hospital stay if longer than 30 days	Any complication (Anastomotic leakage/abscesses, bleeding, small bowel obstruction, stomal ulcera, cardiovascular complications, pulmonary complications, venous thromboembolism, port site complication, other complication)

Trial Locations

Locations (1)

University Hospital Örebro; 🇸🇪 Örebro, Sweden