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| Name | Class |
|---|---|
| Scandinavian Obesity Surgery Registry | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Operated patients | Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic gastric bypass surgery | Procedure | laparoscopic gastric bypass surgery |
|
| 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 |
| 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 |
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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.
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Patients undergoing bariatric surgery in Sweden
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| Name | Affiliation | Role |
|---|---|---|
| Ingmar Näslund, MD, PhD | The Scandinavian Obesity Surgery Registry | Study Chair |
| Erik Stenberg, MD | Region Örebro County | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Örebro | Örebro | 70185 | Sweden |
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| Label | URL |
|---|---|
| The Scandinavian Obesity Surgery Registry | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Operated Patients | Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012 laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Operated Patients | All patients operated with a laparoscopic gastric bypass procedure in Sweden during the inclusion period. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serious Complications | Graded as Clavien 3b or more (for patients entered in the registry after January 1st 2010) | All patients operated after Jan 1, 2010 | Posted | Count of Participants | Participants | 30 days or the postoperative hospital stay if longer than 30 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Operated Patients | Patients undergoing laparoscopic gastric bypass surgery between 1st of May 2007 until 30th of september 2012 laparoscopic gastric bypass surgery: laparoscopic gastric bypass surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Serious adverse event | Gastrointestinal disorders | Systematic Assessment | Any postoperative complication resulting in intervention under general anesthesia, organ failure or mortality (that is Clavien-Dindo 3b or more) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any postoperative complication | Gastrointestinal disorders | Systematic Assessment | Any deviation from a normal postoperative course (that is Clavien-Dindo grade 1 or more) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Erik Stenberg | Region Örebro län, Sweden AND Örebro University, Sweden | +46196021000 | erik.stenberg@regionorebrolan.se |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Operating Time | length of the operation | Posted | Mean | Standard Deviation | minutes | operation |
|
|
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| Secondary | Length of Stay | Length of stay after the primary operation | Posted | Mean | Standard Deviation | days | 30 days or the postoperative hospital stay if longer than 30 days |
|
|
|
| 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) | Posted | Count of Participants | Participants | 30 days or the postoperative hospital stay if longer than 30 days |
|
|
|
| 11 |
| 25,038 |
| 630 |
| 18,737 |
| 2,180 |
| 25,038 |
|
|
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