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PANDA-trial.


- candidate number10840
- NTR NumberNTR3224
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-jan-2012
- Secondary IDsNL37950.068.11 METC MUMC
- Public TitlePANDA-trial.
- Scientific TitleA multicentre, randomized control trial after pancreaticoduodenectomy, within an enhanced recovery after surgery pathway. Prophylactic postoperative drainage versus a no drain policy.
- ACRONYM
- hypothesisWe hypothesized that avoidance of drainage after pancreaticoduodenectomy leads to less secondary interventions, less complications and a reduction in length of hospital stay.
- Healt Condition(s) or Problem(s) studiedPancreaticoduodenectomy, Postoperative recovery, Complications
- Inclusion criteria1. Diagnosis of pancreas head tumour;
2. Elective Pancreaticoduodenectomy;
3. Age > 18 years;
4. ASA I / II / III;
5. Written informed consent.
- Exclusion criteria1. Emergency surgery;
2. ASA IV / V;
3. Impossibility to obtain informed consent;
4. Pregnancy.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2012
- planned closingdate1-mrt-2015
- Target number of participants360
- InterventionsControl group (group A): Conventional prophylactic drainage applied adhering to routine protocols, drain removal on POD 4;
Study group (group B): No prophylactic drainage after surgery.
- Primary outcome1. Need for radiological or surgical drainage;
2. Overall complications.
- Secondary outcome1. Postoperative lenght of hospital stay;
2. Functional recovery;
3. Mortality;
4. Readmission.
- Timepoints3 years duration of the study.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. R.M. Dam, van
- CONTACT for SCIENTIFIC QUERIESDr. R.M. Dam, van
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- PublicationsConlon, K.C., et al., Prospective randomized clinical trial of the value of intraperitoneal drainage after pancreatic resection. Ann Surg, 2001. 234(4): p. 487-93; discussion 493-4.
- Brief summaryRandomized controlled trail to assess the need for prophylactic drainage after pancreaticoduodenectomy.
- Main changes (audit trail)
- RECORD4-jan-2012 - 26-jan-2012


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