Low-pressure versus standard pressure laparoscopic colorectal surgery (PAROS trial): a phase III randomized controlled trial.

TRIAL DESIGN: This is a phase III, double-blind, randomized, controlled trial. METHODS: 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. RESULTS: 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). CONCLUSION: 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. TRIAL REGISTRATION: 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.

Randomized trial comparing low-pressure versus standard-pressure pneumoperitoneum in laparoscopic colectomy: PAROS trial.

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: 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: 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.