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| Name | Class |
|---|---|
| St. Antonius Hospital | OTHER |
| Erasmus Medical Center | OTHER |
| Maastricht University Medical Center | OTHER |
| Universitätsklinikum Hamburg-Eppendorf |
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PANACOTTA is a multicenter randomized controlled trial including patients with symptomatic chronic pancreatitis and a dilated main pancreatic duct to either robot-assisted or open lateral pancreaticojejunostomy. The PANACOTTA trial will assess the post-operative quality of recovery following robot-assisted versus open lateral pancreaticojejunostomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted lateral pancreaticojejunostomy | Experimental |
| |
| Open lateral pancreaticojejunostomy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-assisted lateral pancreaticojejunostomy | Procedure | Robot-assisted |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery (QoR-15) | Primary objective: To assess post-operative mean Quality of Recovery (QoR-15) on post-operative days one through five and cumulative loss of QoR-15 until time of functional recovery of robot-assisted (RA) as compared to open lateral pancreaticojejunostomy (LPJ) in patients with symptomatic chronic pancreatitis and a dilated main pancreatic duct with a normal size pancreatic head. | Daily assessments on Post-operative Day 1 through Day 5 and up to time of functional recovery, defined individually per patient (maximum of 90 days from surgery). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| E. Kilinc | Contact | +31652741059 | e.kilinc@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| M.G. Besselink, Amsterdam UMC | prof. dr. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Recruiting | Amsterdam | Netherlands |
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| OTHER |
| University Medical Center Groningen | OTHER |
| Onze Lieve Vrouwe Gasthuis | OTHER |
| Catharina Ziekenhuis Eindhoven | OTHER |
| Radboud University Medical Center | OTHER |
| Medisch Spectrum Twente | OTHER |
| Leiden University Medical Center | OTHER |
1:1 randomization
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Patient-blinded up to post-operative day 5.
| Open lateral pancreaticojejunostomy | Procedure | Open surgery |
|
| ID | Term |
|---|---|
| D050500 | Pancreatitis, Chronic |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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