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Published in: Trials 1/2020

Open Access 01-12-2020 | Rocuronium | Study protocol

The effect of low- versus normal-pressure pneumoperitoneum during laparoscopic colorectal surgery on the early quality of recovery with perioperative care according to the enhanced recovery principles (RECOVER): study protocol for a randomized controlled study

Authors: Kim I. Albers, Fatih Polat, Ivo F. Panhuizen, Marc M. J. Snoeck, Gert-Jan Scheffer, Hans D. de Boer, Michiel C. Warlé

Published in: Trials | Issue 1/2020

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Abstract

Background

There is increasing evidence for the use of lower insufflation pressures during laparoscopic surgery. Deep neuromuscular blockade allows for a safe reduction in intra-abdominal pressure without compromising the quality of the surgical field. While there is considerable evidence to support superior surgical conditions during deep neuromuscular blockade, there is only a limited amount of studies investigating patient outcomes. Moreover, results are not always consistent between studies and vary between different types of laparoscopic surgery. This study will investigate the effect of low-pressure pneumoperitoneum facilitated by deep NMB on quality of recovery after laparoscopic colorectal surgery.

Methods

The RECOVER study is a multicenter double-blinded randomized controlled trial consisting of 204 patients who will be randomized in a 1:1 fashion to group A, low-pressure pneumoperitoneum (8 mmHg) facilitated by deep neuromuscular blockade (post tetanic count of 1–2), or group B, normal-pressure pneumoperitoneum (12 mmHg) with moderate neuromuscular blockade (train-of-four response of 1–2). The primary outcome is quality of recovery on postoperative day 1, quantified by the Quality of Recovery-40 questionnaire.

Discussion

Few studies have investigated the effect of lower insufflation pressures facilitated by deep neuromuscular blockade on patient outcomes after laparoscopic colorectal procedures. This study will identify whether low pressure pneumoperitoneum and deep neuromuscular blockade will enhance recovery after colorectal laparoscopic surgery and, moreover, if this could be a valuable addition to the Enhanced Recovery After Surgery guidelines.

Trial registration

EudraCT 2018-001485-42. Registered on April 9, 2018. Clinicaltrials.​govNCT03608436. Registered on July 30, 2018.
Appendix
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Metadata
Title
The effect of low- versus normal-pressure pneumoperitoneum during laparoscopic colorectal surgery on the early quality of recovery with perioperative care according to the enhanced recovery principles (RECOVER): study protocol for a randomized controlled study
Authors
Kim I. Albers
Fatih Polat
Ivo F. Panhuizen
Marc M. J. Snoeck
Gert-Jan Scheffer
Hans D. de Boer
Michiel C. Warlé
Publication date
01-12-2020
Publisher
BioMed Central
Keyword
Rocuronium
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04496-8

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