A multicenter randomized controlled trial evaluating the effect of the use of an anti-adhesion barrier for diverting ileostomy on the multidimensional workload in minimally invasive surgery for rectal cancer (YCOG 2005: The ADOBARRIER study)

IF 3.3 4区 医学 Q2 GASTROENTEROLOGY & HEPATOLOGY
Emi Ota, Jun Watanabe, Yusuke Suwa, Masakatsu Numata, Hirokazu Suwa, Hiroki Ohya, Kazuya Nakagawa, Mayumi Ozawa, Itaru Endo
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引用次数: 0

Abstract

Aim

The purpose of this study was to assess whether the use of spray-type anti-adhesion material during diverting ileostomy construction could reduce the surgeon's multidimensional workload, the degree of adhesion, and the operation time in ileostomy closure.

Methods

Patients diagnosed with rectal cancer, who were scheduled for laparoscopic or robotic rectal surgery followed by diverting ileostomy, were single-blindly (patient-blind), randomly assigned to either the AdSpray™ arm or the control arm. The primary endpoint was the multidimensional workload of the ileostomy closure operator (SURG-TLX value).

Results

Between January 2020 and December 2022, 126 patients were enrolled. Five patients were excluded and a total of 121 patients (control arm, n = 60; AdSpray™ arm, n = 61) were analyzed. The baseline factors were well balanced between the two arms. Regarding SURG-TLX in ileostomy closure, operators in the AdSpray™ arm required a significantly lower overall workload than those in the control arm (AdSpray™ arm, 28.1; control arm, 58.9; p < 0.001). Mental, physical, and temporal demands, task complexity, situation stress, and distractions were significantly lower in the AdSpray™ arm (p < 0.001). Operative time was significantly shorter in the AdSpray™ arm (AdSpray™ arm, 58 min; control arm, 65 min; p = 0.040). The degree of adhesion (p < 0.001) and extent of intra-abdominal adhesions (p < 0.001) in ileostomy closure were significantly lower in the AdSpray™ arm.

Conclusions

The use of spray-type anti-adhesion material was associated with a significantly lower SURG-TLX value, lower incidence of adhesion, less severe adhesion, and shorter operative time.

Abstract Image

一项多中心随机对照试验,评估在直肠癌微创手术中使用抗粘连屏障转移回肠造口对多维负荷的影响(YCOG 2005: ADOBARRIER研究)
目的探讨喷雾型抗粘连材料在回肠造口转移过程中是否能减少外科医生的多维工作量、粘连程度和手术时间。方法诊断为直肠癌的患者,计划进行腹腔镜或机器人直肠手术,随后进行回肠转移造口,单盲(患者盲),随机分配到AdSpray™组或对照组。主要终点是回肠造口闭合术者的多维工作量(SURG-TLX值)。结果2020年1月至2022年12月,126例患者入组。排除5例患者,共分析121例患者(对照组,n = 60; AdSpray™组,n = 61)。基线因素在两组之间得到了很好的平衡。在回肠镜造口手术中,AdSpray组的手术人员所需的总工作量明显低于对照组(AdSpray组,28.1;对照组,58.9;p < 0.001)。AdSpray™组的精神、身体和时间需求、任务复杂性、情境压力和分心显著降低(p < 0.001)。AdSpray™组的手术时间明显缩短(AdSpray™组58分钟,对照组65分钟,p = 0.040)。AdSpray™组回肠造口闭合时的粘连程度(p < 0.001)和腹腔内粘连程度(p < 0.001)显著降低。结论喷雾型抗粘连材料的使用可显著降低SURG-TLX值,降低粘连发生率,减轻粘连严重程度,缩短手术时间。
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来源期刊
Annals of Gastroenterological Surgery
Annals of Gastroenterological Surgery GASTROENTEROLOGY & HEPATOLOGY-
CiteScore
5.30
自引率
11.10%
发文量
98
审稿时长
11 weeks
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