leftsided resection pancreas
Conditions
Interventions
1. Scalpel transsection of the pancreas and hand-sewn closure of the pancreatic
remnant
2. Stapler-transsection of the pancreas and stapler-closure of the pancreatic
remnant
Sponsors
Chirurgische Universitätsklinik Heidelberg Duitsland
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: · Age equal or above 18 years · Expected survival time more than 12 months · Patients with at least one of the following pathologic diseases scheduled for elective resection: - Resectable malignancies of the pancreatic body and/or tail - Resectable chronic pancreatitis of the body and/or tail - Resectable benign tumours of the pancreas including neuroendocrine tumours - Resectable pseudocyst of the pancreatic body and/or tail
Exclusion criteria
Exclusion criteria: · Current immunosuppressive therapy · Chemotherapy within 2 weeks before operation · Radiotherapy within 8 weeks before operation · Curative resection is not feasible · Severe psychiatric or neurologic diseases · Drug- and/or alcohol-abuse according to local standards · Participation in another intervention-trial with interference of intervention or outcome · Inability to follow the instructions given by the investigator or interviewer · Expected lack of compliance · Lack of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined primary endpoint: · Occurence of a pancreatic fistula. · Death due to any cause until the postoperative day 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Surgical category · Operating time [min] from resection to beginning of closure of the abdomen · Total operating time [min] · Frequency of burst abdomen · Frequency of wound infection · Frequency of intra-abdominal fluid collection rated as abscess that requires an intervention (surgery, drainage, antibiotic treatment) 2. Non-surgical category · postoperative length of hospital stay · Frequency of new onset diabetes mellitus (necessity of new anti-diabetic drug treatment) · One-year survival | — |
Countries
Netherlands
Outcome results
None listed