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Published in: Trials 1/2019

Open Access 01-12-2019 | Pancreatectomy | Study protocol

Laparoscopic versus open distal pancreatectomy (LAPOP): study protocol for a single center, nonblinded, randomized controlled trial

Authors: Bergthor Björnsson, Per Sandström, Anna Lindhoff Larsson, Claes Hjalmarsson, Thomas Gasslander

Published in: Trials | Issue 1/2019

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Abstract

Background

Earlier nonrandomized studies have suggested that laparoscopic distal pancreatectomy (LDP) is advantageous compared with open distal pancreatectomy (ODP) regarding hospital stay, blood loss, and recovery. Only one randomized study has been conducted showing reduced time to functional recovery after LDP compared with ODP.

Methods

LAPOP is a prospective randomized, nonblinded, parallel-group, single-center superiority trial. Sixty patients with lesions in the pancreatic body or tail that are found by a multidisciplinary tumor board to need surgical resection will be randomized to receive LDP or ODP. The primary outcome variable is postoperative hospital stay, and secondary outcomes include functional recovery (defined as no need for intravenous medications or fluids and as the ability of an ambulatory patient to perform activities of daily life), perioperative bleeding, complications, need for pain medication, and quality of life comparison.

Discussion

The LAPOP trial will test the hypothesis that LDP reduces postoperative hospital stay compared with ODP.

Trial registration

ISRCTN, 26912858. Registered on 28 September 2015.
Appendix
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Metadata
Title
Laparoscopic versus open distal pancreatectomy (LAPOP): study protocol for a single center, nonblinded, randomized controlled trial
Authors
Bergthor Björnsson
Per Sandström
Anna Lindhoff Larsson
Claes Hjalmarsson
Thomas Gasslander
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3460-y

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