Low-pressure versus standard pressure laparoscopic colorectal surgery (PAROS trial): a phase III randomized controlled trial.
Adult
Aged
Aged, 80 and over
Colectomy
/ methods
Colorectal Neoplasms
/ surgery
Double-Blind Method
Female
Follow-Up Studies
France
/ epidemiology
Humans
Laparoscopy
/ methods
Male
Middle Aged
Morbidity
/ trends
Postoperative Complications
/ epidemiology
Pressure
Prospective Studies
Treatment Outcome
Young Adult
Journal
The British journal of surgery
ISSN: 1365-2168
Titre abrégé: Br J Surg
Pays: England
ID NLM: 0372553
Informations de publication
Date de publication:
19 08 2021
19 08 2021
Historique:
received:
03
12
2020
revised:
26
01
2021
accepted:
29
01
2021
pubmed:
24
3
2021
medline:
17
12
2021
entrez:
23
3
2021
Statut:
ppublish
Résumé
This is a phase III, double-blind, randomized, controlled trial. In this trial, patients with laparoscopic colectomy were assigned to either low pressure (LP: 7 mmHg) or standard pressure (SP: 12 mmHg) at a ratio of 1 : 1. The aim of this trial was to assess the impact of low-pressure pneumoperitoneum during laparoscopic colectomy on postoperative recovery. The primary endpoint was the duration of hospital stay. The main secondary endpoints were postoperative pain, consumption of analgesics and postoperative morbidity. Some 138 patients were enrolled, of whom 11 were excluded and 127 were analysed: 62 with LP and 65 with SP. Duration of hospital stay (3 versus 4 days; P = 0.010), visual analog scale (0.5 versus 2.0; P = 0.008) and analgesic consumption (level II: 73 versus 88 per cent; P = 0.032; level III: 10 versus 23 per cent; P = 0.042) were lower with LP. Morbidity was not significantly different between the two groups (10 versus 17 per cent; P = 0.231). Using low-pressure pneumoperitoneum in laparoscopic colonic resection improves postoperative recovery, shortening the duration of hospitalization and decreasing postoperative pain and analgesic consumption. This suggests that low pressure should become the standard of care for laparoscopic colectomy. NCT03813797. The aim of this trial was to assess the impact of low-pressure pneumoperitoneum during laparoscopic colectomy. The study proved that using low pressure in laparoscopic colonic resection improves postoperative recovery, decreasing length of hospitalization, postoperative pain and analgesic consumption.
Autres résumés
Type: plain-language-summary
(eng)
The aim of this trial was to assess the impact of low-pressure pneumoperitoneum during laparoscopic colectomy. The study proved that using low pressure in laparoscopic colonic resection improves postoperative recovery, decreasing length of hospitalization, postoperative pain and analgesic consumption.
Identifiants
pubmed: 33755088
pii: 6181762
doi: 10.1093/bjs/znab069
doi:
Banques de données
ClinicalTrials.gov
['NCT03813797']
Types de publication
Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
998-1005Commentaires et corrections
Type : CommentIn
Type : CommentIn
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Informations de copyright
© The Author(s) 2021. Published by Oxford University Press on behalf of BJS Society Ltd. All rights reserved. For permissions, please email: journals.permissions@oup.com.