Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 Jun 7;20(1):332.
doi: 10.1186/s13063-019-3442-0.

Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial

Joerg Kaiser  1 , Willem Niesen  1 , Pascal Probst  1 , Thomas Bruckner  2 , Colette Doerr-Harim  1 , Oliver Strobel  1 , Phillip Knebel  1 , Markus K Diener  1 , André L Mihaljevic  1 , Markus W Büchler  1 , Thilo Hackert  3
Affiliations

Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial

Joerg Kaiser et al. Trials. .

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.

Keywords: Distal pancreatectomy; Drain; Pancreatic fistula; Postoperative complications.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Enrollment, interventions, and assessment schedule of the PANDRA II trial: course of examinations (modified SPIRIT figure)
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Fong Y, Brennan MF, Brown K, Heffernan N, Blumgart LH. Drainage is unnecessary after elective liver resection. Am J Surg. 1996;171:158–162. doi: 10.1016/S0002-9610(99)80092-0. - DOI - PubMed
    1. Budd DC, Cochran RC, Fouty WJ., Jr Cholecystectomy with and without drainage. A randomized, prospective study of 300 patients. Am J Surg. 1982;143:307–309. doi: 10.1016/0002-9610(82)90097-6. - DOI - PubMed
    1. Alvarez Uslar R, Molina H, Torres O, Cancino A. Total gastrectomy with or without abdominal drains. A prospective randomized trial. Rev Esp Enferm Dig. 2005;97:562–569. doi: 10.4321/S1130-01082005000800004. - DOI - PubMed
    1. Kim J, Lee J, Hyung WJ, Cheong JH, Chen J, Choi SH, Noh SH. Gastric cancer surgery without drains: a prospective randomized trial. J Gastrointest Surg. 2004;8:727–732. doi: 10.1016/j.gassur.2004.05.018. - DOI - PubMed
    1. Merad F, Yahchouchi E, Hay JM, Fingerhut A, Laborde Y, Langlois-Zantain O. Prophylactic abdominal drainage after elective colonic resection and suprapromontory anastomosis: a multicenter study controlled by randomization. French Associations for Surgical Research. Arch Surg. 1998;133:309–314. doi: 10.1001/archsurg.133.3.309. - DOI - PubMed

Publication types