C25.0 C25.1 K86.0 K86.1 C24.0 C24.1 C24.8 C24.9 K86.8 K86.9
Conditions
Interventions
Group 1: Patients after pylorus-preserving pancreaticoduodenectomy followed by Child reconstruction and an additional Braun anastomosis between afferent and efferent loop of the gastrojejunostomy
Grou
Sponsors
Klinikum Rechts der Isar der TU München
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Patients with benign or malignant diseases of the pancreas, the distal bile duct and the duodenum requiring a pylorus-preserving pancreaticoduodenectomy 2. Surgical reconstruction by Child reconstruction defined as pancreaticojejunostomy followed by hepaticojejunostomy followed by duodenojejunostomy 3. Age = 18 years. 4. Ability to understand the character and individual consequences of the trial and to sign the informed consent
Exclusion criteria
Exclusion criteria: 1. Patients undergoing classical Kausch-Whipple resection 2. Patients undergoing pylorus-preserving pancreaticoduodenectomy with requirement of intraoperative arterial resection 3. Patients with pylorus-preserving pancreaticoduodenectomy with requirement of multivisceral resections 4. Laparoscopic or laparoscopic-assisted pancreatic surgery 5. Distal pancreatectomy 6. Enucleations 7. Patients after previous major GI-surgery in medical history 8. Pregnant or breast-feeding women 9. Planned re-laparotomy up to 30 days after initial surgery Emergency surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of clinically relevant POPF according to the current definition of the International Study group of Pancreatic surgery (ISGPS) within a postoperative period of 30 (+10) days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence and severity of clinically relevant postoperative delayed gastric emptying according to ISPGS-definition (30 POD) 2. Incidence and severity of postoperative haemorrhages according to ISGPS-definition (30 POD) 3. Incidence and severity of postoperative complications according to the Clavien-Dindo classification within 30 days after surgery 5. Complication comprehensive index after operation during hospital stay 6. In-hospital, 30- and 90-day mortality rates 7. Incidence of reoperations and reinterventions 8. Incidence of anastomotic leaks of the Braun enteroenterostomy 9. Quality of life after pancreas resection (EORTC QLQ-C30) 10. Length of hospital stay (measured between day 0 of the operation and discharge) 11. Length of stay on ICU (measured from day 0 of the operation) 12. Histopathological tumor stage 13. Postoperative pain according to the Visual Analogue Scale (VAS 0-10) 14. Incidence of re-admission within the duration of the study after discharge | — |
Countries
Germany
Contacts
Public ContactDaniel Reim
Klinik und Poliklinik für Chirurgie der TU München
Outcome results
None listed