Diseases of the pancreatic head requiring partial pancreatoduodenectomy C25.0 D37.70
Conditions
Interventions
Group 1: robotic pancreatoduodenectomy (RPD)
Group 2: open pancreatoduodenectomy (OPD)
Sponsors
Universitätsklinikum Heidelberg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Planned elective partial pancreaticoduodenectomy for any indication 2. Possibility to perform RPD and OPD as judged by the treating pancreatic surgeon 3. Age = 18 years 4. Ability of subject to understand character and individual consequences of the clinical trial 5. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Borderline or non-resectable carcinomas of the pancreatic head as defined by the National Comprehensive Cancer Network guidelines (1) 2. Distant metastases 3. American Society of Anaesthesiologists (ASA) Score >3 4. Participation in another interventional trial with interference of intervention and outcome of this trial 5. Expected lack of compliance or language problems
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall postoperative morbidity in terms of the com-prehensive complication index (CCI) within 90 days after index operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Feasibility of recruitment - Duration of surgery - Intraoperative blood loss - Serious adverse intraoperative events - Conversion rate in the robotic Group - Rate of a. microscopically complete margin clearance (>0.1cm margin clearance, R0(CRM-)) b. microscopic margin clearance =0.1cm (R0(CRM+)) c. microscopic margin involvement (R1) - Total number of resected lymph nodes and number of tumour-positive lymph nodes in patients with malignant tumours - Mortality within 90 days - Quality of recovery (QoR-15) - Time to functional recovery - Total length of intensive care unit stay within 90 days - Length of hospital stay for index Operation - Rate of superficial and deep surgical site infections (according to CDC) within 30 days - Rate and severity of postoperative pancreas specific complications (according to ISGPS and ISGLS): pancreatic fistula, postpancreatectomy haemorrhage, delayed gastric emptying, biliary leak, chyle leak within 90 days - Rate of non-surgical re-interventions within 90 days - Rate of re-operations within 90 days from index operation - Number of hospital re-admissions within 90 days. - Pain (Numeric Rating Scale) on postoperative day 1, 2 and 3 - Health-related quality of life measured by the SF-36 - Overall costs - Evaluation of surgeons’ mental workload/stress | — |
Countries
Germany
Contacts
Public ContactThilo Hackert
Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Outcome results
None listed