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The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture.
The aim of this prospective randomized controlled study is to determine the benefit-risk ratio (success rate, complication rate, tolerance) for patients with biliodigestive anastomosis by either continuous or interrupted suture. A biliodigestive anastomosis is a surgical connection between the common bile duct (ductus choledochus) and the digestive tract to prevent interference of bile flow. Indications for a biliodigestive anastomosis include total or partial resection of the pancreas and duodenum (PPPD, Whipple procedure) for pancreatic tumors, tumors of the biliary tract or duodenum, and biliary tract reconstructions during liver transplantation or advanced liver resections. Furthermore a biliodigestive anastomosis can be required to manage the injury of the biliary tract and infectious and traumatic structures of the biliary tract. Biliodigestive anastomoses can be performed by continuous or interrupted suture. The aim of this study is to determine the difference between continuous and interrupted suture for biliodigestive anastomoses, as advantages and disadvantages of each technique have not been determined. Only patients receiving their first biliodigestive anastomosis will be included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous suture technique | Experimental | The BDA is performed as continuous suture with two separate all-layer suture for the behind - and front-wall of the anastomosis |
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| Interrupted suture technique | Active Comparator | The BDA is performed as interrupted suture with two separate all-layer suture for the behind - and front-wall of the anastomosis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous suture technique | Procedure | The BDA is performed as continuous suture with two separate all-layer suture for the behind - and front-wall of the anastomosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to complete the biliodigestive anastomosis | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Reißfelder, MD | christoph.reissfelder@uniklinikum-dresden.de | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, TU Dresden, Germany | Dresden | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36723996 | Derived | Seifert L, von Renesse J, Seifert AM, Sturm D, Meisterfeld R, Rahbari NN, Kahlert C, Distler M, Weitz J, Reissfelder C. Interrupted versus continuous suture technique for biliary-enteric anastomosis: randomized clinical trial. BJS Open. 2023 Jan 6;7(1):zrac163. doi: 10.1093/bjsopen/zrac163. |
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| Interrupted suture technique | Procedure | The BDA is performed as interrupted suture with two separate all-layer suture for the behind - and front-wall of the anastomosis |
|