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

Abstract

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

Effect of Surgical Humidification on Inflammation and Peritoneal Trauma in Colorectal Cancer Surgery: A Randomized Controlled Trial

“…However, an informative recent phase 3 RCT shows that lowering insufflation pressure is associated with a reduced LOS. 4 The positive benefit of lowering insufflation CO 2 pressure on inflammatory markers aligns with other approaches such as HW-CO2 found in this RCT. 1 , 2 …”

“…It would appear that reducing laparoscopic pressure alone affords multiple clinical and health-economic benefits as reported in a phase 3 RCT. 4 Others have examined a range of parameters such as pain in patients undergoing colorectal surgeries, finding no benefit in terms of reduction with HW-CO2 compared with DC-CO2 5 or some benefit more generally with abdominal surgery as reviewed by Binda. 6 There is a modest benefit in maintaining normothermia with HW-CO2.…”

Does deep neuromuscular blockade provide improved outcomes in low pressure laparoscopic colorectal surgery? A single blinded randomized pilot study

“…A recent randomized controlled trial supports the notion of using low IAP as the standard of care for laparoscopic colectomy. 25 However, debate continues as to whether deep neuromuscular blockade is required to counter the potential reduction in vision. 24,26 In both the deep and moderate neuromuscular block groups in this study, only 2 requests were made for an increase in the IAP, lending support to the notion that the low IAP allows for suitable laparoscopic views to perform laparoscopic colorectal surgery, as is recommended by the European Association for Endoscopic Surgery.…”

“…This study focuses on laparoscopic colorectal surgery as the most established ERAS protocol both in the study centre and worldwide. A recent randomized controlled trial supports the notion of using low IAP as the standard of care for laparoscopic colectomy 25 . However, debate continues as to whether deep neuromuscular blockade is required to counter the potential reduction in vision 24,26 .…”

A novel method for monitoring abdominal compliance to optimize insufflation pressure during laparoscopy

“…Sufficient surgical workspace results in a shorter procedure duration and reduces complications [ 5 ]. The application of high pressures impairs organ perfusion, hampers mechanical ventilation and results in postoperative pain and delayed recovery [ 6 , 7 ]. For optimal surgical conditions, the insufflation pressure setting should be based on whether the benefits of gaining workspace volume outweigh the drawbacks of applying a higher insufflation pressure [ 8 , 9 ].…”