| - candidate number | 28250 |
| - NTR Number | NTR6871 |
| - ISRCTN | ISRCTN no longer applicable |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 22-nov-2017 |
| - Secondary IDs | G12.059 Commissie Medische Ethiek, Leids Universitair Medische Centrum |
| - Public Title | Perioperatieve pijnbestrijding en uitkomsten na pancreasresecties in het LUMC |
| - Scientific Title | Perioperative analgesic management and outcomes in patients undergoing pancreatectomy in a Dutch tertiary referral center |
| - ACRONYM | |
| - hypothesis | Epidral analgesia has superior pain management outcomes. On the other hand we hypothize EA requires more aggressive hemodynamic support, leading to higher risk of postoperative complications. |
| - Healt Condition(s) or Problem(s) studied | Pancreatectomy, Perioperative analgesic management |
| - Inclusion criteria | All consecutive patients undergoing elective or emergency (open procedure) pancreatectomy for (suspected) malignant disease |
| - Exclusion criteria | Laparoscopic procedure. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | no |
| - group | Parallel |
| - Type | 2 or more arms, non-randomized |
| - Studytype | observational |
| - planned startdate | 1-dec-2017 |
| - planned closingdate | 1-aug-2018 |
| - Target number of participants | 300 |
| - Interventions | Observational study in patient with epidural versus non-epidural analgesia |
| - Primary outcome | Mean NRS on first ten postoperative days |
| - Secondary outcome | - Failure rate of initial analgesia - (Non-)surgical complications - Fluid balances on first five postoperative days - Length of hospital stay |
| - Timepoints | - Data collection start dec 2017 - Data analyses start feb 2018 - First draft apr 2018 - Submission jun 2018 |
| - Trial web site | |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | J.V. Groen |
| - CONTACT for SCIENTIFIC QUERIES | J.V. Groen |
| - Sponsor/Initiator | Leiden University Medical Center (LUMC) |
| - Funding (Source(s) of Monetary or Material Support) | Bas Mulder Award (grant UL2015-7665) from the Alpe d'HuZes foundation/Dutch Cancer Society |
| - Publications | |
| - Brief summary | Epidural analgesia (EA) is the current golden standard for perioperative pain management in most abdominal surgery. However, as demonstrated by the variety of reported use of EA (ranging approximately from 10%-84%), the golden standard in patients undergoing pancreatectomy has yet to be determined. The reported benefits from EA in abdominal surgery might not apply to patients undergoing pancreatectomy. In contrast to the beneficial reported effect on postoperative complications of EA in abdominal surgery, recent studies described an adverse effect of EA on postoperative complications, Intensive Care Unit (ICU) admissions and length of hospital stay (LOS). Although some studies reported a (marginally) better postoperative pain control in patient with EA compared to other analgesic management options, detailed reports on pain outcomes after pancreatectomy are sparse. The aim of this study is to evaluate the current practice of analgesic management and outcomes in patients undergoing pancreatectomy in our tertiary referral center. |
| - Main changes (audit trail) | |
| - RECORD | 22-nov-2017 - 15-dec-2017 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl