Published in:
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.