Randomized trial comparing low-pressure versus standard-pressure pneumoperitoneum in laparoscopic colectomy: PAROS trial.
Clinical Trials, Phase III as Topic
Colectomy
/ adverse effects
Colon
/ physiopathology
Double-Blind Method
France
Humans
Laparoscopy
/ adverse effects
Length of Stay
Pain, Postoperative
/ etiology
Pneumoperitoneum, Artificial
/ adverse effects
Postoperative Complications
/ etiology
Pressure
Randomized Controlled Trials as Topic
Recovery of Function
Rectum
/ physiopathology
Time Factors
Treatment Outcome
Colectomy
Laparoscopy
Low-pressure pneumoperitoneum
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
22 Feb 2020
22 Feb 2020
Historique:
received:
03
09
2019
accepted:
04
02
2020
entrez:
24
2
2020
pubmed:
24
2
2020
medline:
19
12
2020
Statut:
epublish
Résumé
Laparoscopy, by its minimally invasive nature, has revolutionized digestive and particularly colorectal surgery by decreasing post-operative pain, morbidity, and length of hospital stay. In this trial, we aim to assess whether low pressure in laparoscopic colonic surgery (7 mm Hg instead of 12 mm Hg) could further reduce pain, analgesic consumption, and morbidity, resulting in a shorter hospital stay. The PAROS trial is a phase III, double-blind, randomized controlled trial. We aim to recruit 138 patients undergoing laparoscopic colectomy. Participants will be randomly assigned to either a low-pressure group (7 mm Hg) or a standard-pressure group (12 mm Hg). The primary outcome will be a comparison of length of hospital stay between the two groups. Secondary outcomes will compare post-operative pain, consumption of analgesics, morbidity within 30 days, technical and oncological quality of the surgical procedure, time to passage of flatus and stool, and ambulation. All adverse events will be recorded. Analysis will be performed on an intention-to-treat basis. This research received the approval from the Committee for the Protection of Persons and was the subject of information to the ANSM. This search is saved in the ID-RCB database under registration number 2018-A03028-47. This research is retrospectively registered January 23, 2019, at http://clinicaltrials.gov/ed under the name "LaPAroscopic Low pRessure cOlorectal Surgery (PAROS)". This trial is ongoing.
Sections du résumé
BACKGROUND
BACKGROUND
Laparoscopy, by its minimally invasive nature, has revolutionized digestive and particularly colorectal surgery by decreasing post-operative pain, morbidity, and length of hospital stay. In this trial, we aim to assess whether low pressure in laparoscopic colonic surgery (7 mm Hg instead of 12 mm Hg) could further reduce pain, analgesic consumption, and morbidity, resulting in a shorter hospital stay.
METHODS AND ANALYSIS
METHODS
The PAROS trial is a phase III, double-blind, randomized controlled trial. We aim to recruit 138 patients undergoing laparoscopic colectomy. Participants will be randomly assigned to either a low-pressure group (7 mm Hg) or a standard-pressure group (12 mm Hg). The primary outcome will be a comparison of length of hospital stay between the two groups. Secondary outcomes will compare post-operative pain, consumption of analgesics, morbidity within 30 days, technical and oncological quality of the surgical procedure, time to passage of flatus and stool, and ambulation. All adverse events will be recorded. Analysis will be performed on an intention-to-treat basis.
TRIAL REGISTRATION
BACKGROUND
This research received the approval from the Committee for the Protection of Persons and was the subject of information to the ANSM. This search is saved in the ID-RCB database under registration number 2018-A03028-47. This research is retrospectively registered January 23, 2019, at http://clinicaltrials.gov/ed under the name "LaPAroscopic Low pRessure cOlorectal Surgery (PAROS)". This trial is ongoing.
Identifiants
pubmed: 32087762
doi: 10.1186/s13063-020-4140-7
pii: 10.1186/s13063-020-4140-7
pmc: PMC7036186
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
216Références
Surg Endosc. 2002 Jul;16(7):1121-43
pubmed: 12015619
Surg Endosc. 2003 Apr;17(4):636-40
pubmed: 12574925
Am J Surg. 2014 Jul;208(1):143-50
pubmed: 24503370
Ann Surg. 2009 Jan;249(1):39-44
pubmed: 19106674
Urology. 2016 Aug;94:274-80
pubmed: 27130263
Br J Surg. 2010 Aug;97(8):1180-6
pubmed: 20602506
Ann Surg. 2011 Nov;254(5):738-43; discussion 743-4
pubmed: 21997816
Anesth Analg. 2017 Jun;124(6):1794-1801
pubmed: 28452822
Clin Nutr. 2012 Dec;31(6):783-800
pubmed: 23099039
Surg Endosc. 2011 Apr;25(4):1121-6
pubmed: 20872022
Lancet. 2004 Apr 10;363(9416):1187-92
pubmed: 15081650
Lancet. 2002 Jun 29;359(9325):2224-9
pubmed: 12103285
Arch Surg. 2007 Mar;142(3):298-303
pubmed: 17372057
Surg Endosc. 2018 May;32(5):2300-2311
pubmed: 29098436