Kang Sung Il, Kim Sohyun, Kim Jae Hwang
Department of Surgery, College of Medicine, Yeungnam University, 170, Hyeonchung-ro, Nam-Gu, Daegu, 42415, Korea.
Int J Colorectal Dis. 2022 Apr;37(4):835-841. doi: 10.1007/s00384-022-04117-7. Epub 2022 Mar 3.
Our previously published clinical studies described the short-term outcomes of a newly developed intraluminal fecal diverting device (FDD). FDD was a safe and effective substitute for a defunctioning stoma. However, the long-term efficacy and safety of this device remain unknown. We investigated the long-term outcomes of the use of the FDD as a substitute for a defunctioning stoma.
We examined the medical records of patients who participated in our two previous FDD clinical studies. The main outcome was the number of patients with bowel continuity for 2 years after undergoing the FDD procedure or defunctioning stoma creation.
Between May 2015 and July 2018, 85 patients were screened for inclusion in this study. Of those, 27 patients underwent a defunctioning ileostomy after proctectomy. The remaining 58 underwent the FDD procedure after proctectomy. Seventy-two patients (ileostomy group, n = 22; FDD group, n = 50) with a follow-up duration > 24 months were included in this analysis. The mean duration of fecal diversion was significantly shorter (p < 0.001) in the FDD group (3.1 [1.6-6.1] weeks) than in the ileostomy group (16.7 [10.0-31.6] weeks). However, the rate of permanent stoma creation was not statistically different between the two groups (ileostomy and FDD groups, 13.6% [3/22] and 10.0% [5/50], respectively; p = 0.693).
The FDD procedure is a feasible substitute for a defunctioning stoma after proctectomy. Multicenter large-scaled clinical studies are required to validate our results.
我们之前发表的临床研究描述了一种新开发的腔内粪便转流装置（FDD）的短期疗效。FDD是一种安全有效的造口去功能化替代物。然而，该装置的长期疗效和安全性尚不清楚。我们研究了使用FDD替代造口去功能化的长期疗效。
我们查阅了参与之前两项FDD临床研究的患者的病历。主要结局是接受FDD手术或造口去功能化造口术后2年保持肠道连续性的患者数量。
2015年5月至2018年7月期间，85例患者被筛选纳入本研究。其中，27例患者在直肠切除术后接受了去功能化回肠造口术。其余58例在直肠切除术后接受了FDD手术。本分析纳入了72例随访时间>24个月的患者（回肠造口术组，n = 22；FDD组，n = 50）。FDD组的平均粪便转流持续时间（3.1 [1.6 - 6.1]周）显著短于回肠造口术组（16.7 [10.0 - 31.6]周）（p < 0.001）。然而，两组之间永久性造口形成率无统计学差异（回肠造口术组和FDD组分别为13.6% [3/22]和10.0% [5/50]；p = 0.693）。
FDD手术是直肠切除术后造口去功能化的一种可行替代方法。需要多中心大规模临床研究来验证我们的结果。
