Abstract Background In minimally invasive surgery of the sigmoid colon and rectum a retractor sponge has been introduced as an alternative to the Trendelenburg position. This randomized clinical trial (RCT) compared postoperative duration of hospital stay and perioperative outcomes in patients with sigmoid or rectal cancer undergoing sponge-assisted versus Trendelenburg position surgery. Methods The SPONGE trial is a single-centre RCT nested within the Dutch nationwide prospective observational cohort of patients with colorectal cancer, and follows the Trials within Cohorts (TwiCs) design. Patients with sigmoid or rectal cancer undergoing elective laparoscopic or robotic surgery were randomized to either sponge-assisted or Trendelenburg surgery on a 1:1 basis using block randomization. Duration of postoperative hospital stay was the primary outcome and was compared using the Mann–Whitney U test. Secondary endpoints included the proportion of complications, readmissions, or mortality versus the χ2 test in intention-to-treat and per-protocol analyses. This trial was not blinded for patients in the intervention arm or physicians. Results Between November 2015 and June 2021, 82 patients were randomized to sponge-assisted surgery and 81 to Trendelenburg surgery. After post-randomization exclusion, 150 patients remained for analyses (75 patients per arm). There was no statistically significant difference in median duration of hospital stay (5 days versus 4 days, respectively; P = 0.06), 30-day postoperative complications (30 per cent versus 31 per cent; P = 1.00), readmission rate (8 per cent versus 15 per cent; P = 0.30), or mortality (0 per cent versus 1 per cent, P = 1.00). The per-protocol analysis showed similar results. No adverse device events were seen. Conclusion Sponge-assisted laparoscopic/robotic surgery does not reduce the duration of hospital stay, or perioperative morbidity or mortality. Trial registration NCT02574013 (http://www.clinicaltrials.gov)

中文翻译：

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腹腔镜乙状结肠癌和直肠癌手术中海绵辅助手术与特伦德伦伯卧位手术（SPONGE 试验）：随机临床试验

摘要 背景在乙状结肠和直肠的微创手术中，引入了牵开海绵作为特伦德伦堡位置的替代方案。这项随机临床试验 (RCT) 比较了接受海绵辅助手术与特伦德伦伯卧位手术的乙状结肠癌或直肠癌患者的术后住院时间和围手术期结果。 方法SPONGE 试验是一项单中心随机对照试验，嵌套在荷兰全国结直肠癌患者前瞻性观察队列中，并遵循队列内试验 (TwiCs) 设计。接受择期腹腔镜或机器人手术的乙状结肠癌或直肠癌患者使用区组随机化以 1:1 的比例随机接受海绵辅助手术或特伦德伦伯卧位手术。术后住院时间是主要结果，并使用曼-惠特尼 U 检验进行比较。次要终点包括意向治疗和符合方案分析中并发症、再入院或死亡率与 χ2 检验的比例。这项试验对干预组的患者或医生没有设盲。 结果2015 年 11 月至 2021 年 6 月期间，82 名患者被随机接受海绵辅助手术，81 名患者被随机接受特伦德伦堡手术。随机分组后排除后，留下 150 名患者进行分析（每组 75 名患者）。中位住院时间（分别为 5 天和 4 天；P = 0.06）、术后 30 天并发症（30% 和 31%；P = 1.00）、再入院率（8 例）之间没有统计学差异。 % 与 15%；P = 0.30），或死亡率（0% 与 1%，P = 1.00）。按方案分析显示了相似的结果。未发现不良设备事件。 结论海绵辅助腹腔镜/机器人手术不会减少住院时间或围手术期发病率或死亡率。 试用注册NCT02574013 (http://www.clinicaltrials.gov)