Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery

Study Overview
=================
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.

Official Title
-----------------
Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery

Conditions
-----------------
Postoperative Complications

Intervention / Treatment
-----------------
* Procedure: laparoscopic gastric bypass surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Operated patients<br>Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012 | Procedure: laparoscopic gastric bypass surgery<br>* laparoscopic gastric bypass surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bariatric surgery, postoperative complications