Low‐ versus standard‐ pneumoperitoneum in patients undergoing robot‐assisted radical prostatectomy: a randomised, triple‐blinded study

医学 前列腺切除术 气腹 双盲 盲法研究 腹腔镜前列腺根治术 泌尿科 外科 安慰剂 内科学 前列腺 腹腔镜检查 癌症 替代医学 病理
作者
Hayder Alhusseinawi,Lotte Sander,Pernille Mølgaard Rosenvinge,Sarah L. Jensen,Niels Henrik Bruun,Pernille Skjold Kingo,Jørgen Bjerggaard Jensen,Sten Rasmussen
出处
期刊:BJUI [Wiley]
卷期号:132 (5): 560-567 被引量:8
标识
DOI:10.1111/bju.16099
摘要

Objective To investigate the effectiveness and impact of low‐pressure pneumoperitoneum (Pnp) on postoperative quality of recovery (QoR) and surgical workspace (SWS) in patients with prostate cancer undergoing robot‐assisted radical prostatectomy (RARP). Patients and Methods A randomised, triple‐blinded trial was conducted in a single centre in Denmark from March 2021 to January 2022. A total of 98 patients with prostate cancer undergoing RARP were randomly assigned to either low‐pressure Pnp (7 mmHg) or standard‐pressure Pnp (12 mmHg). Co‐primary outcomes were postoperative QoR measured via the QoR‐15 questionnaire on postoperative Day 1 (POD1), POD3, POD14, and POD30, and SWS assessed intraoperatively by a blinded assessor (surgeon) via a validated SWS scale. Data analysis was performed according to the intention‐to‐treat principle. Results Patients who underwent RARP at low Pnp pressure demonstrated better postoperative QoR on POD1 (mean difference = 10, 95% confidence interval [CI] 4.4–15.5), but no significant differences were observed in the SWS (mean difference = 0.25, 95% CI −0.02 to 0.54). Patients allocated to low‐pressure Pnp experienced statistically higher blood loss than those in the standard‐pressure Pnp group (mean difference = 67 mL, P = 0.01). Domain analysis revealed significant improvements in pain ( P = 0.001), physical comfort ( P = 0.007), and emotional state ( P = 0.006) for patients with low‐pressure Pnp. This trial was registered at ClinicalTrials.gov , NCT04755452, on 16/02/2021. Conclusion Performing RARP at low Pnp pressure is feasible without compromising the SWS and improves postoperative QoR, including pain, physical comfort, and emotional state, compared to the standard pressure.
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