NCT03813797: PAROS

LaPAroscopic Low pRessure cOlorectal Surgery

Completed NA Last updated 8 October 2020

What this trial tests

NA trial testing Airseal® in Malignant or Benign Pathology in 138 participants. Completed in 26 June 2020.

Timeline

7 January 2019

Primary endpoint
25 May 2020

26 June 2020

Quick facts

Lead sponsor	University Hospital, Bordeaux
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	138
Start date	7 January 2019
Primary completion	25 May 2020
Estimated completion	26 June 2020
Sites	1 location across France

Drugs / interventions tested

• Airseal®
• Standard Insufflation

Conditions studied

• Malignant or Benign Pathology — all drugs for Malignant or Benign Pathology →

Sponsor

University Hospital, Bordeaux

Who can join

18 and older, any sex, with Malignant or Benign Pathology. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Laparoscopy by its mini-invasive character has revolutionized abdominal and colorectal surgery but certain limitations remains (post-operative pain due to pneumoperitoneum, pneumoperitoneum stability, visibility during bleeding, smoke evacuation). The medical device for continuous pressure insufflation during laparoscopic procedures Airseal® would allow the maintenance of pneumoperitoneum at a lower pressure. The stable low pressure (7mmHg) is described in the literature for 15 years as the best way to reduce scapular pain, but until the marketing of Airseal, working at 7mmHg was not possible because the space of work was not stable. Moreover, this device makes it possible to obtain a better vision because of the evacuation of the fumes potentially leading to a reduction in the operating time.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Low-pressure versus standard pressure laparoscopic colorectal surgery (PAROS trial): a phase III randomized controlled trial.
   Celarier S, Monziols S, Célérier B, Assenat V, et al · · 2021 · cited 31× · PMID 33755088 · DOI 10.1093/bjs/znab069