Postoperative Complications
Conditions
Keywords
bariatric surgery, postoperative complications
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.
Interventions
PROCEDURElaparoscopic gastric bypass surgery
laparoscopic gastric bypass surgery
Sponsors
Scandinavian Obesity Surgery Registry
Region Örebro County
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Operated Patients All patients operated with a laparoscopic gastric bypass procedure in Sweden during the inclusion period. | 25,038 |
| Total | 25,038 |
Baseline characteristics
| Characteristic | Operated Patients |
|---|---|
| Age, Continuous | 41.1 years STANDARD_DEVIATION 10.97 |
| Region of Enrollment Sweden | 25038 participants |
| Sex: Female, Male Female | 19017 Participants |
| Sex: Female, Male Male | 6021 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 11 / 25,038 |
| other Total, other adverse events | 2,180 / 25,038 |
| serious Total, serious adverse events | 630 / 18,737 |
Outcome results
Primary
Serious Complications
Graded as Clavien 3b or more (for patients entered in the registry after January 1st 2010)
Time frame: 30 days or the postoperative hospital stay if longer than 30 days
Population: All patients operated after Jan 1, 2010
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Operated Patients | Serious Complications | 630 Participants |
Secondary
Length of Stay
Length of stay after the primary operation
Time frame: 30 days or the postoperative hospital stay if longer than 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Operated Patients | Length of Stay | 2.3 days | Standard Deviation 3.17 |
Secondary
Operating Time
length of the operation
Time frame: operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Operated Patients | Operating Time | 77.2 minutes | Standard Deviation 38.1 |
Secondary
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)
Time frame: 30 days or the postoperative hospital stay if longer than 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Operated Patients | Specific Postoperative Complications | 2180 Participants |