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Clinical Trial
. 2023 Dec;25(12):2403-2413.
doi: 10.1111/codi.16787. Epub 2023 Oct 27.

Low-impact laparoscopy in colorectal resection-A multicentric randomised trial comparing low-pressure pneumoperitoneum plus microsurgery versus low-pressure pneumoperitoneum alone: The PAROS II trial

Arthur Marichez  1   2 , Audrey Eude  1 , Mathieu Martenot  1 , Bertrand Celerier  1 , Maylis Capdepont  1   2 , Eric Rullier  1 , Quentin Denost  3 , Benjamin Fernandez  1   2
Affiliations
Clinical Trial

Low-impact laparoscopy in colorectal resection-A multicentric randomised trial comparing low-pressure pneumoperitoneum plus microsurgery versus low-pressure pneumoperitoneum alone: The PAROS II trial

Arthur Marichez et al. Colorectal Dis. 2023 Dec.

Abstract

Introduction: Low-pressure pneumoperitoneum (LLP) in laparoscopy colorectal surgery (CS) has resulted in reduced hospital stay and lower analgesic consumption. Microsurgery (MS) in CS is a technique that has a significant impact with respect to postoperative pain. The combination of MS plus LLP, known as low-impact laparoscopy (LIL), has never been applied in CS. Therefore, this trial will assess the efficacy of LLP plus MS versus LLP alone in terms of decreasing postoperative pain 24 h after surgery, without taking opioids.

Method: PAROS II will be a prospective, multicentre, outcome assessor-blinded, randomised controlled phase III clinical trial that compares LLP plus MS versus LLP alone in patients undergoing laparoscopic surgery for colonic or upper rectal cancer or benign pathology. The primary outcome will be the number of patients with postoperative pain 24 h after the surgery, as defined by a visual analogue scale rating ≤3 and without taking opioids. Overall, PAROS II aims to recruit 148 patients for 50% of patients to reach the primary outcome in the LLP plus MS arm, with 80% power and an 5% alpha risk.

Conclusion: The PAROS II trial will be the first phase III trial to investigate the impact of LIL, including LLP plus MS, in laparoscopic CS. The results may improve the postoperative recovery experience and decrease opioid consumption after laparoscopic CS.

Trial registration: ClinicalTrials.gov NCT04742881.

Keywords: colorectal surgery; laparoscopy; low-pressure pneumoperitoneum; microsurgery.

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References

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