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

Björnsson, Bergthor ; Sandström, Per ; Larsson, Anna Lindhoff ; Hjalmarsson, Claes LU and Gasslander, Thomas (2019) In Trials 20(1).
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... (More)

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.

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author
; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Distal pancreatectomy, Laparoscopic, Minimally invasive, Pancreatic surgery
in
Trials
volume
20
issue
1
article number
356
publisher
BioMed Central (BMC)
external identifiers
  • scopus:85067291023
  • pmid:31196166
ISSN
1745-6215
DOI
10.1186/s13063-019-3460-y
language
English
LU publication?
yes
id
0ee816b3-2d4c-490c-a23d-8e1c34d6cf6a
date added to LUP
2019-06-28 08:59:20
date last changed
2024-03-19 15:30:26
@article{0ee816b3-2d4c-490c-a23d-8e1c34d6cf6a,
  abstract     = {{<p>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.</p>}},
  author       = {{Björnsson, Bergthor and Sandström, Per and Larsson, Anna Lindhoff and Hjalmarsson, Claes and Gasslander, Thomas}},
  issn         = {{1745-6215}},
  keywords     = {{Distal pancreatectomy; Laparoscopic; Minimally invasive; Pancreatic surgery}},
  language     = {{eng}},
  month        = {{06}},
  number       = {{1}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{Trials}},
  title        = {{Laparoscopic versus open distal pancreatectomy (LAPOP) : Study protocol for a single center, nonblinded, randomized controlled trial}},
  url          = {{http://dx.doi.org/10.1186/s13063-019-3460-y}},
  doi          = {{10.1186/s13063-019-3460-y}},
  volume       = {{20}},
  year         = {{2019}},
}