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| Name | Class |
|---|---|
| Lund University | OTHER |
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The study compares regular use of surgical drains and no use of surgical drains in patients subjected to pancreaticoduodenectomy with expected low to intermediate risk for post operative pancreatic fistula.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drain | Active Comparator | Surgical drains used as routine |
|
| No drain | Experimental | No surgical drain used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drain | Procedure | Surgical drains are placed as a standard of care (control arm) or not (experimental arm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall morbidity rate | Post operative morbidity | 90 days post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality rate (in-hospital, 30 and 90 days) | 90 days post operatively | |
| Severe morbidity rate as classified by Clavien-Dindo >3 | 90 days post operatively | |
| Fistula rate according to ISGPF |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bergthor Björnsson | Contact | +46703766890 | bergthor.bjornsson@liu.se |
| Name | Affiliation | Role |
|---|---|---|
| Bergthor Björnsson | Linkoeping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linkoping University Hospital | Recruiting | Linköping | 582 72 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42083018 | Derived | Wallon S, Williamsson C, Karlsson V, Wennerblom J, Bratlie SO, Sandstrom P, Tingstedt B, Bjornsson B. Postoperative drainage after pancreatoduodenectomy: a randomized controlled trial among patients with intermediate and low risks for pancreatic fistula-DRAIN1. Trials. 2026 May 5;27(1):357. doi: 10.1186/s13063-026-09762-9. |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| ID | Term |
|---|---|
| D004322 | Drainage |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Randomized controlled study
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| No drain | Procedure | Surgical drains are placed as a standard of care (control arm) or not (experimental arm) |
|
| 90 days post operatively |
| Intraabdominal abscess rate | 90 days post operatively |
| Wound infection rate | 90 days post operatively |
| Delayed gastric emptying according to ISGPF | 90 days post operatively |
| Postpancreatectomy bleeding according to ISGPF | 90 days post operatively |
| Need of interventional radiology | 90 days post operatively |
| Need for reoperation | 90 days post operatively |
| Hospital stay | 90 days post operatively |
| Readmission rate | 90 days post operatively |
| Skanes University Hospital | Recruiting | Lund | Sweden |
|
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |