Department of digestive Surgery, Colorectal Unit, Bordeaux University Hospital, 1 Avenue de Magellan, Pessac, 33600, France.
Department of Anesthesia ans Critical Care, Bordeaux University Hospital, 1 Avenue de Magellan, Pessac, 33600, France.
Trials. 2020 Feb 22;21(1):216. doi: 10.1186/s13063-020-4140-7.
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.
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.
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.
腹腔镜技术通过其微创特性，降低了术后疼痛、发病率和住院时间，从而彻底改变了消化科和特别是结直肠外科的手术方式。在本试验中，我们旨在评估腹腔镜结肠手术中的低压力（7mmHg 而非 12mmHg）是否能进一步减轻疼痛、减少镇痛药的使用和发病率，从而缩短住院时间。
PAROS 试验是一项 III 期、双盲、随机对照试验。我们计划招募 138 例接受腹腔镜结肠切除术的患者。参与者将被随机分配到低压力组（7mmHg）或标准压力组（12mmHg）。主要结局将是比较两组患者的住院时间。次要结局将比较术后疼痛、镇痛药的使用、30 天内的发病率、手术的技术和肿瘤学质量、排气和排便时间以及活动能力。所有不良事件都将被记录。分析将基于意向治疗进行。
这项研究得到了保护人员委员会的批准，并向 ANSM 进行了信息报备。这项研究在 ID-RCB 数据库中以注册号 2018-A03028-47 进行了保存。这项研究于 2019 年 1 月 23 日在 http://clinicaltrials.gov/ed 以“LaPAroscopic Low pRessure cOlorectal Surgery (PAROS)”的名称进行了回顾性注册。该试验正在进行中。
