eprintid: 26548
rev_number: 13
eprint_status: archive
userid: 1589
dir: disk0/00/02/65/48
datestamp: 2019-08-06 15:27:14
lastmod: 2019-08-29 08:41:55
status_changed: 2019-08-06 15:27:14
type: article
metadata_visibility: show
creators_name: Kaiser, Joerg
creators_name: Niesen, Willem
creators_name: Probst, Pascal
creators_name: Bruckner, Thomas
creators_name: Doerr-Harim, Colette
creators_name: Strobel, Oliver
creators_name: Knebel, Phillip
creators_name: Diener, Markus K.
creators_name: Mihaljevic, André L.
creators_name: Büchler, Markus W.
creators_name: Hackert, Thilo
title: Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial
subjects: 610
divisions: 910200
divisions: 911800
keywords: Distal pancreatectomy, Drain, Postoperative complications, Pancreatic fistula
abstract: Background: The placement of prophylactic intra-abdominal drains has been common practice in abdominal operations including pancreatic surgery. The PANDRA trial showed that the omission of drains following pancreatic head resection was non-inferior to intra-abdominal drainage in terms of postoperative reinterventions and superior in terms of clinically relevant pancreatic fistula rate and fistula-associated complications. The aim of the present PANDRA II trial is to evaluate the clinical outcome with versus without prophylactic drain placement after distal pancreatectomy.

Methods: The PANDRA II trial is a mono-center, randomized controlled, non-inferiority trial with two parallel study groups. In the control group at least one passive intra-abdominal drain is placed at the pancreatic resection margin. In the experimental group no drains are placed. The primary endpoint of this trial will be the Comprehensive Complication Index (CCI) measuring all postoperative complications within 90 days. Secondary endpoints are in-hospital mortality and morbidity, including the rates of postoperative pancreatic fistula, chyle leak, postpancreatectomy hemorrhage, delayed gastric emptying, reinterventions and reoperations, surgical site infection, and abdominal fascia dehiscence. Moreover, length of hospital stay, duration of intensive care unit stay, and the rate of readmission after discharge from hospital (up to day 90 after surgery) are assessed. We will need to analyze 252 patients to test the hypothesis that no drainage is non-inferior to drain placement in terms of the CCI (δ 7.5 points) in a one-sided t test with a one-sided level of significance of 2.5% and a power of 80%.

Discussion: The results of the PANDRA II trial will help to evaluate the effect of an omission of prophylactic intraperitoneal drainage on the rate of complications after open or minimally invasive distal pancreatectomy.

Trial registration: German Clinical Trials Register (DRKS), DRKS00013763. Registered on 6 March 2018.
date: 2019
publisher: BioMed Central
id_scheme: DOI
ppn_swb: 1672410975
own_urn: urn:nbn:de:bsz:16-heidok-265480
language: eng
bibsort: KAISERJOERABDOMINALD2019
full_text_status: public
publication: Trials
volume: 20
number: 332
place_of_pub: London
pagerange: 1-7
issn: 1468-6694
citation:   Kaiser, Joerg ; Niesen, Willem ; Probst, Pascal ; Bruckner, Thomas ; Doerr-Harim, Colette ; Strobel, Oliver ; Knebel, Phillip ; Diener, Markus K. ; Mihaljevic, André L. ; Büchler, Markus W. ; Hackert, Thilo  (2019) Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial.  Trials, 20 (332).  pp. 1-7.  ISSN 1468-6694     
document_url: https://archiv.ub.uni-heidelberg.de/volltextserver/26548/1/13063_2019_Article_3442.pdf