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经肛门内镜微创手术治疗低位直肠肿瘤的临床研究

Vacuum-assisted early transanal closure of leaking low colorectal anastomoses: the CLEAN study.

机构信息

Department of Surgery, Academic Medical Center, University of Amsterdam, PO Box 22660, 1100 DD, Amsterdam, The Netherlands.

Department of Surgery, Academic Hospital Maastricht, Maastricht, The Netherlands.

出版信息

Surg Endosc. 2018 Jan;32(1):315-327. doi: 10.1007/s00464-017-5679-6. Epub 2017 Jun 29.

DOI:10.1007/s00464-017-5679-6
PMID:28664443
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5770507/
Abstract

INTRODUCTION

Non-healing of anastomotic leakage can be observed in up to 50% after total mesorectal excision for rectal cancer. This study investigates the efficacy of early transanal closure of anastomotic leakage after pre-treatment with the Endosponge therapy.

METHODS

In this prospective, multicentre, feasibility study, transanal suturing of the anastomotic defect was performed after vacuum-assisted cleaning of the presacral cavity. Primary outcome was the proportion of patients with a healed anastomosis at 6 months after transanal closure. Secondary, healing at last follow-up, continuity, direct medical costs, functionality and quality of life were analysed.

RESULTS

Between July 2013 and July 2015, 30 rectal cancer patients with a leaking low colorectal anastomosis were included, of whom 22 underwent neoadjuvant radiotherapy. Median follow-up was 14 (7-29) months. At 6 months, the anastomosis had healed in 16 (53%) patients. At last follow-up, anastomotic integrity was found in 21 (70%) and continuity was restored in 20 (67%) patients. Non-healing at 12 months was observed in 10/29 (34%) patients overall, and in 3/14 (21%) when therapy started within three weeks following the index operation. Major LARS was reported in 12/15 (80%) patients. The direct medical costs were €8933 (95% CI 7268-10,707) per patient.

CONCLUSION

Vacuum-assisted early transanal closure of a leaking anastomosis after total mesorectal excision with 73% preoperative radiotherapy showed that acceptable anastomotic healing rates and stoma reversal rates can be achieved. Early diagnosis and start of treatment seems crucial.

摘要

简介

直肠癌全直肠系膜切除术后吻合口漏的不愈合率可达 50%。本研究探讨了在术前使用 Endosponge 治疗后,通过经肛门早期闭合吻合口漏的疗效。

方法

在这项前瞻性、多中心、可行性研究中,在真空辅助清洗骶前腔后,对吻合口缺陷进行经肛门缝合。主要结局是经肛门闭合后 6 个月时吻合口愈合的患者比例。次要结局包括最后一次随访时的愈合情况、连续性、直接医疗费用、功能和生活质量。

结果

2013 年 7 月至 2015 年 7 月期间,共纳入 30 例低位直肠吻合口漏的直肠癌患者,其中 22 例行新辅助放疗。中位随访时间为 14 个月(7-29 个月)。在 6 个月时,16 例(53%)患者的吻合口愈合。在最后一次随访时,21 例(70%)患者的吻合口完整性得到保留,20 例(67%)患者的连续性得到恢复。29 例患者中有 10 例(34%)在 12 个月时未愈合,其中 3 例(21%)在指数手术后 3 周内开始治疗。15 例中有 12 例(80%)报告有严重的 LARS。每位患者的直接医疗费用为 8933 欧元(95%CI 7268-10707 欧元)。

结论

术前放疗 73%的全直肠系膜切除术后,通过真空辅助早期经肛门闭合吻合口漏,吻合口愈合率和造口还纳率达到了可接受的水平。早期诊断和开始治疗似乎至关重要。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2814/5770507/efe4ab59f413/464_2017_5679_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2814/5770507/4ae81ddee3da/464_2017_5679_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2814/5770507/d7d68671e7cb/464_2017_5679_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2814/5770507/816c8a000b83/464_2017_5679_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2814/5770507/efe4ab59f413/464_2017_5679_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2814/5770507/4ae81ddee3da/464_2017_5679_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2814/5770507/d7d68671e7cb/464_2017_5679_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2814/5770507/816c8a000b83/464_2017_5679_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2814/5770507/efe4ab59f413/464_2017_5679_Fig4_HTML.jpg

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