1. Randomized trial comparing low-pressure versus standard-pressure pneumoperitoneum in laparoscopic colectomy: PAROS trial
- Author
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Quentin Denost, M. Capdepont, S. Celarier, C. Fleming, V. Assenat, M. O. Francois, G. Napolitano, E. Rullier, S. Monziols, and P. Carles
- Subjects
medicine.medical_specialty ,Time Factors ,Colon ,medicine.medical_treatment ,Analgesic ,Medicine (miscellaneous) ,030230 surgery ,Laparoscopic colectomy ,law.invention ,03 medical and health sciences ,Study Protocol ,0302 clinical medicine ,Postoperative Complications ,Randomized controlled trial ,Pneumoperitoneum ,Double-Blind Method ,law ,medicine ,Pressure ,Humans ,Pharmacology (medical) ,Laparoscopy ,Adverse effect ,Colectomy ,Randomized Controlled Trials as Topic ,lcsh:R5-920 ,Pain, Postoperative ,medicine.diagnostic_test ,business.industry ,General surgery ,Rectum ,Recovery of Function ,Length of Stay ,medicine.disease ,Colorectal surgery ,Low-pressure pneumoperitoneum ,Treatment Outcome ,Clinical Trials, Phase III as Topic ,030220 oncology & carcinogenesis ,France ,lcsh:Medicine (General) ,business ,Pneumoperitoneum, Artificial - Abstract
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.
- Published
- 2020