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| Name | Class |
|---|---|
| Leiden University Medical Center | OTHER |
| Catharina Ziekenhuis Eindhoven | OTHER |
| Erasmus Medical Center | OTHER |
| Medisch Spectrum Twente |
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The DIPLOMA-3 trial is an international, multicenter, patient-blinded randomized controlled trial comparing laparoscopic and robot-assisted left-sided pancreatectomy. Patients with an indication for elective left-sided pancreatecomy for benign or premalignant lesions in the body or tail of the pancreas and considered eligible will be randomized between laparoscopic and robot-assisted resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic minimally invasive left-sided pancreatecomy | Active Comparator | Laparoscopic minimally invasive left-sided pancreatecomy |
|
| Robot-assisted minimally invasive left-sided pancreatecomy | Experimental | Robot-assisted minimally invasive left-sided pancreatecomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic minimally invasive left-sided pancreatecomy | Procedure | Laparoscopic minimally invasive left-sided pancreatecomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| COMPOS-panc left score | The COMPOS-panc left score is a recently developed, severity-weighted composite outcome measure for pancreatic surgery. It combines perioperative and postoperative outcomes into a single composite outcome measure. This score includes the following parameters, measured at 90-days postoperative: unplanned blood transfusion, emergency conversion to open surgery, postoperative pancreatic fistula (POPF), postpancreatectomy hemorrhage (PPH), other complications requiring intervention, multi-organ failure, mortality, length of hospital stay and readmission requiring intervention. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total hospital-related costs | To examine total hospital-related costs, the following costs will be considered up to 90 days postoperative:
| 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Operative outcomes | Total operative time (first skin incision to fully closed skin incisions, min.); Time of reconstruction phase; Estimated intraoperative blood loss (mL); Serious intraoperative complications; Conversion; Reason for conversion; Surgeon's mental strain (measured at the end of surgery). | Surgery |
| Length of hospital stay |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Charlotte Baggerman van Houweninge, MD | Contact | +31618037377 | c.e.baggermanvanhouweninge@amsterdamUMC.nl |
| Name | Affiliation | Role |
|---|---|---|
| Prof. Mohammad Abu Hilal, MD PhD | University of Jordan | Principal Investigator |
| Prof. Marc Besselink, MD, PhD | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Recruiting | Amsterdam | Netherlands |
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| OTHER |
| Maastricht University Medical Center | OTHER |
| University Medical Center Groningen | OTHER |
| Onze Lieve Vrouwe Gasthuis | OTHER |
1:1 randomization
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Patient-blinded up to post-operative day 5. Blinded adjudication committee assessing the primary endpoint.
| Robot-assisted minimally invasive left-sided pancreatecomy | Procedure | Robot-assisted minimally invasive left-sided pancreatecomy |
|
| Spleen-preservation rate and spleen-preservation technique | Compare L-MILP and R-MILP for spleen-preservation rate and spleen-reservation technique (Kimura versus Warshaw technique) | Surgery |
| Pancreatic surgery specific complications | Complications including pancreatic fistula, delayed gastric emptying, postoperative bleeding, wound infection, other gastrointestinal leakage, re-interventions (radiographic, endoscopic, surgical), ICU admission, in hospital, 30- and 90-day mortality. | 90 days |
Days from surgery to discharge; Readmission rates; Total of hospitalized days. |
| 90 days postoperatively |
| Patient-reported outcomes | (Health-related) Quality of Life measurement using validated EORTC questionnaires: Baseline, 1-, 3-, 6- months and 1 year | 1 year postoperative |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| C538110 | Pancreatic adenoma |
| D010181 | Pancreatic Cyst |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D003560 | Cysts |
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