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Ultrasonic dissection versus electrocautery dissection in laparoscopic cholecystectomy for acute cholecystitis: a randomized controlled trial (SONOCHOL-trial)
World Journal of Emergency Surgery ( IF 6.0 ) Pub Date : 2024-11-13 , DOI: 10.1186/s13017-024-00565-4 My Blohm, Gabriel Sandblom, Lars Enochsson, Yücel Cengiz, Haytham Bayadsi, Joakim Hennings, Angelica Diaz Pannes, Erik Stenberg, Kerstin Bewö, Johanna Österberg
World Journal of Emergency Surgery ( IF 6.0 ) Pub Date : 2024-11-13 , DOI: 10.1186/s13017-024-00565-4 My Blohm, Gabriel Sandblom, Lars Enochsson, Yücel Cengiz, Haytham Bayadsi, Joakim Hennings, Angelica Diaz Pannes, Erik Stenberg, Kerstin Bewö, Johanna Österberg
Laparoscopic cholecystectomy with ultrasonic dissection presents a compelling alternative to conventional electrocautery. The evidence for elective cholecystectomy supports the adoption of ultrasonic dissection, citing advantages such as reduced operating time, diminished bleeding, shorter hospital stays and decreased postoperative pain and nausea. However, the efficacy of this procedure in emergency surgery and patients diagnosed with acute cholecystitis remains uncertain. The aim of this study was to compare outcomes of electrocautery and ultrasonic dissection in patients with acute cholecystitis. A randomized, parallel, double-blinded, multicentre controlled trial was conducted across eight Swedish hospitals. Eligible participants were individuals aged ≥ 18 years with acute cholecystitis lasting ≤ 7 days. Laparoscopic cholecystectomy was performed in the emergency setting as soon as local circumstances permitted. Random allocation to electrocautery or ultrasonic dissection was performed in a 1:1 ratio. The primary endpoint was the total complication rate, analysed using an intention-to-treat approach. The primary outcome was analysed using logistic generalized estimated equations. Patients, postoperative caregivers, and follow-up personnel were blinded to group assignment. From September 2019 to March 2023, 300 patients were enrolled and randomly assigned to electrocautery dissection (n = 148) and ultrasonic dissection (n = 152). No significant difference in complication rate was observed between the groups (risk difference [RD] 1.6%, 95% confidence interval [CI], − 7.2% to 10.4%, P = 0.720). No significant disparities in operating time, conversion rate, hospital stay or readmission rates between the groups were noted. Haemostatic agents were more frequently used in electrocautery dissection (RD 10.6%, 95% CI, 1.3% to 19.8%, P = 0.025). Ultrasonic dissection and electrocautery dissection demonstrate comparable risks for complications in emergency surgery for patients with acute cholecystitis. Ultrasonic dissection is a viable alternative to electrocautery dissection or can be used as a complementary method in laparoscopic cholecystectomy for acute cholecystitis. The trial was registered prior to conducting the research on http://clinical.trials.gov , NCT03014817.
中文翻译:
超声清扫术与电烙术清扫术在腹腔镜胆囊切除术治疗急性胆囊炎:一项随机对照试验(SONOCHOL 试验)
腹腔镜胆囊切除术联合超声夹层是传统电烙术的一种令人信服的替代方案。择期胆囊切除术的证据支持采用超声清扫术,其优点是手术时间缩短、出血减少、住院时间短以及术后疼痛和恶心减少。然而,该手术在急诊手术和诊断为急性胆囊炎患者中的疗效仍不确定。本研究的目的是比较急性胆囊炎患者电烙术和超声清扫术的结局。在瑞典 8 家医院进行了一项随机、平行、双盲、多中心对照试验。符合条件的参与者是 ≥ 18 岁患有急性胆囊炎持续 ≤ 7 天的个体。一旦当地情况允许,在紧急情况下立即进行腹腔镜胆囊切除术。以 1:1 的比例随机分配到电烙术或超声解剖组。主要终点是总并发症发生率,使用意向性治疗方法进行分析。使用 logistic 广义估计方程分析主要结局。患者、术后护理人员和随访人员对分组分配不知情。从 2019 年 9 月到 2023年3月,入组 300 例患者,并随机分配到电烙夹层 (n = 148) 和超声夹层 (n = 152)。两组之间并发症发生率无显著差异 (风险差 [RD] 1.6%,95% 置信区间 [CI],-7.2% 至 10.4%,P = 0.720)。两组之间在手术时间、转化率、住院率或再入院率方面没有显著差异。 止血剂更常用于电烙夹层 (RD 10.6%,95% CI,1.3% 至 19.8%,P = 0.025)。超声夹层和电烙夹层显示急性胆囊炎患者急诊手术并发症的风险相当。超声清扫术是电烙术清扫术的可行替代方案,也可作为急性胆囊炎腹腔镜胆囊切除术的补充方法。该试验是在对 http://clinical.trials.gov 、 NCT03014817 进行研究之前注册的。
更新日期:2024-11-14
中文翻译:
超声清扫术与电烙术清扫术在腹腔镜胆囊切除术治疗急性胆囊炎:一项随机对照试验(SONOCHOL 试验)
腹腔镜胆囊切除术联合超声夹层是传统电烙术的一种令人信服的替代方案。择期胆囊切除术的证据支持采用超声清扫术,其优点是手术时间缩短、出血减少、住院时间短以及术后疼痛和恶心减少。然而,该手术在急诊手术和诊断为急性胆囊炎患者中的疗效仍不确定。本研究的目的是比较急性胆囊炎患者电烙术和超声清扫术的结局。在瑞典 8 家医院进行了一项随机、平行、双盲、多中心对照试验。符合条件的参与者是 ≥ 18 岁患有急性胆囊炎持续 ≤ 7 天的个体。一旦当地情况允许,在紧急情况下立即进行腹腔镜胆囊切除术。以 1:1 的比例随机分配到电烙术或超声解剖组。主要终点是总并发症发生率,使用意向性治疗方法进行分析。使用 logistic 广义估计方程分析主要结局。患者、术后护理人员和随访人员对分组分配不知情。从 2019 年 9 月到 2023年3月,入组 300 例患者,并随机分配到电烙夹层 (n = 148) 和超声夹层 (n = 152)。两组之间并发症发生率无显著差异 (风险差 [RD] 1.6%,95% 置信区间 [CI],-7.2% 至 10.4%,P = 0.720)。两组之间在手术时间、转化率、住院率或再入院率方面没有显著差异。 止血剂更常用于电烙夹层 (RD 10.6%,95% CI,1.3% 至 19.8%,P = 0.025)。超声夹层和电烙夹层显示急性胆囊炎患者急诊手术并发症的风险相当。超声清扫术是电烙术清扫术的可行替代方案,也可作为急性胆囊炎腹腔镜胆囊切除术的补充方法。该试验是在对 http://clinical.trials.gov 、 NCT03014817 进行研究之前注册的。