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经括约肌间瘘切开术联合一期成形皮瓣移植治疗括约肌间型肛瘘的多中心随机对照研究方案

Anal fistulotomy with one-stage shaped skin grafting for intersphincter anal fistulas: study protocol on a multicentre randomised controlled trial.

机构信息

Department of Anorectal Surgery, the First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, 510000, China.

Department of Gastrointestinal Surgery, Guangzhou Panyu Hexian Memorial Hospital, Guangzhou, 510000, China.

出版信息

Trials. 2023 Jul 22;24(1):470. doi: 10.1186/s13063-023-07495-7.

DOI:10.1186/s13063-023-07495-7
PMID:37481545
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10363312/
Abstract

BACKGROUND: Anal fistulas are mainly treated via surgery. They can be difficult to treat without surgical intervention. Numerous procedures, such as fistulectomy and fistulotomy, are performed to treat anal fistulas and achieve good effects. However, the wounds created through fistulectomy and fistulotomy take a long time to heal. Therefore, a multicentre randomised controlled trial (RCT) is proposed to study the efficacy of one-stage shaped skin grafting at the surgical wound to heal low simple intersphincter anal fistulas. METHODS: This study is a multicentre, hospital-based RCT. It will be performed at three hospitals. A total of 104 patients with low simple intersphincter anal fistulas who meet the inclusion criteria will be included in this trial and will be allocated randomly to two groups (test and control groups). The patients in the test group will receive one-stage anal fistulotomy surgery combined with shaped skin grafting, and those in the control group will undergo anal fistulotomy only. All the operations will be performed by attending colorectal surgeons or surgeons of a higher level. Effectiveness and safety indicators will be observed, recorded and analysed. DISCUSSION: Anal fistulotomy can heal low simple intersphincter anal fistulas effectively and safely with a low recurrence rate. Skin grafts promote wound epithelisation significantly. We believe that skin grafting can treat low simple intersphincter fistulas with a short healing time. TRIAL REGISTRATION: Chinese Clinical Trial Register, ChiCTR2000039174. Registered on 28 October 2020.

摘要

背景：肛瘘主要通过手术治疗。如果不进行手术干预，治疗难度较大。有许多手术方法，如肛瘘切除术和瘘管切开术，用于治疗肛瘘并取得良好效果。然而，肛瘘切除术和瘘管切开术所造成的伤口需要很长时间才能愈合。因此，提出了一项多中心随机对照试验（RCT），以研究手术伤口一期成形植皮治疗低位单纯括约肌间肛瘘的疗效。

方法：本研究为多中心、医院为基础的 RCT，将在 3 家医院进行。共有 104 例符合纳入标准的低位单纯括约肌间肛瘘患者将被纳入本试验，并随机分为两组（试验组和对照组）。试验组患者接受一期肛瘘切开术联合成形植皮术，对照组患者仅接受肛瘘切开术。所有手术均由主治结直肠外科医生或更高水平的外科医生进行。观察、记录和分析有效性和安全性指标。

讨论：肛瘘切开术可有效、安全地治愈低位单纯括约肌间肛瘘，复发率低。植皮术可显著促进伤口上皮化。我们认为植皮术可以治疗愈合时间短的低位单纯括约肌间瘘。

试验注册：中国临床试验注册中心，ChiCTR2000039174。注册于 2020 年 10 月 28 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/1fb77fd9c98a/13063_2023_7495_Fig8_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/56c61e261bac/13063_2023_7495_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/5119334b7d0a/13063_2023_7495_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/931d117abe31/13063_2023_7495_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/a98c3b08e7e7/13063_2023_7495_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/01054b927451/13063_2023_7495_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/b6cf0554fdd1/13063_2023_7495_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/e06228ae9f3f/13063_2023_7495_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/1fb77fd9c98a/13063_2023_7495_Fig8_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/56c61e261bac/13063_2023_7495_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/5119334b7d0a/13063_2023_7495_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/931d117abe31/13063_2023_7495_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/a98c3b08e7e7/13063_2023_7495_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/01054b927451/13063_2023_7495_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/b6cf0554fdd1/13063_2023_7495_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/e06228ae9f3f/13063_2023_7495_Fig7_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/beda/10363312/1fb77fd9c98a/13063_2023_7495_Fig8_HTML.jpg

相似文献

[1]
Anal fistulotomy with one-stage shaped skin grafting for intersphincter anal fistulas: study protocol on a multicentre randomised controlled trial.

Trials. 2023-7-22

[2]
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[3]
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[4]
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[5]
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[6]
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[7]
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[8]
Fistulectomy and primary sphincteroplasty (FIPS) to prevent keyhole deformity in simple anal fistula: a single-center retrospective cohort study.

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[9]
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[10]
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本文引用的文献

[1]
Long Term Outcomes of Split-Thickness Skin Grafting to the Plantar Foot.

J Foot Ankle Surg. 2020

[2]
Contemporary surgical practice in the management of anal fistula: results from an international survey.

Tech Coloproctol. 2019-7-31

[3]
One stage fistulectomy for high anal fistula with reconstruction of anal sphincter without fecal diversion.

Asian J Surg. 2019-2-6

[4]
Sample size considerations for n-of-1 trials.

Stat Methods Med Res. 2017-9-7

[5]
The outcome of fistulotomy for anal fistula at 1 year: a prospective multicentre French study.

Colorectal Dis. 2016-3

[6]
Modern management of anal fistula.

World J Gastroenterol. 2015-1-7

[7]
Long-term outcome of low perianal fistulas treated by fistulotomy: a multicenter study.

Int J Colorectal Dis. 2015-2

[8]
Fistulotomy in the tertiary setting can achieve high rates of fistula cure with an acceptable risk of deterioration in continence.

J Gastrointest Surg. 2013-9-4

[9]
Fistulotomy and sphincter reconstruction in the treatment of complex fistula-in-ano: long-term clinical and manometric results.

Ann Surg. 2012-5

[10]
Three-dimensional endoanal ultrasonographic assessment of an anal fistula with and without H(2)O(2) enhancement.

World J Gastroenterol. 2009-10-14

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