Clinical trial NCT00951002: The Efficacy of Human Acellular Dermal Matrix in the Treatment of Anal Fistula
Official title: A Multicenter Clinical Trial to Evaluate the Efficacy of Human Acellular Dermal Matrix in the Treatment of Anal Fistula
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anal Fistula
Treatment
Postoperative Complications
Acellular Dermal Matrix
Keywords: anal fistula
acellular dermal matrix
treatment
postoperative complications
recurrence
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Medical College Shandong University
name: Beijing Anorectal Hospital
name: The Central Hospital of China Aerospace Corporation
name: Children's Hospital of Hebei Province
name: The 85th Hosptial of P.L.A
name: Shandong Provincial Hospital
name: Peking University Third Hospital
name: Shenzhen People's Hospital
name: The Second Artillery General Hospital
name: Dongzhimen Hospital, Beijing
name: Shenyang Anorectal Hospital
name: Wuhan Iron and Steel Workers' Hospital
First posted: 2009-08-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hospitalized patients with complex anal fistula

Brief summary: The purpose of this study is to determine whether human acellular dermal matrix plug is effective in the treatment of anal fistula

Detailed description: Recently, the use of biomaterial for the treatment of anal fistula has drawn great interest. The advantages of this technique include simple and repeatable application, preservation of sphincter integrity, minimal patient discomfort, and the ability for subsequent surgical options if needed. Champagne et al reported using a biologic absorbable anal fistula plug which is made from lyophilized porcine small intestinal submucosa (Surgisis®). In their series of 46 patients treated with the anal fistula plug, a success rate of 83 percent was achieved at a median follow-up of 12 months. In addition, evaluation of the functional outcome after fistula closure showed no impairment of continence with significant improvement in quality of life showed. However, the long term success rates of Surgisis® are variable according to other studies.

Human acellular dermal matrix (ADM) is a biologic material consists of dermis without its cellular components. Early and rapid revascularization of the implanted ADM, as was shown in our previous experimental study, is thought to enhance resistance to infection and contamination. These properties make ADM an attractive alternative for the treatment of anal fistula. The ability of ADM to become vascularized and remodeled by autologous cells may be advantageous for anal fistulas healing.

The purpose of this study is to determine whether human acellular dermal matrix plug is effective in the treatment of anal fistula.

Eligibility criteria: Inclusion Criteria:

* complex anal fistula

Exclusion Criteria:

* pregnancy or lactation
* with operation contraindication
* allergic constitution to heterogeneous protein
* complicated with tumor
* complicated with acute infection

Primary outcomes:
measure: postoperative complications
timeFrame: 01/07/2011
Secondary outcomes:
measure: recurrence rate
timeFrame: 01/07/2011
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anorectal Hospital
state: Beijing
city: Beijing
country: China
facility: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: The Central Hospital of China Aerospace Corporation
state: Beijing
city: Beijing
country: China
facility: The Second Artillery General Hospital
state: Beijing
city: Beijing
country: China
facility: General Surgery, Beijing Chao Yang Hospital
state: Beijing
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: Hebei Children's Hospital
state: Hebei
city: Wuhan
country: China
facility: General Staff Hospital of Wuhan Iron and Steel (Group) Corp
state: Hubei
city: Shenyang
country: China
facility: Shenyang Anorectal Hospital
state: Liaoning
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: The Second Affiliated Hospital of Medical College Shandong University
state: Shandong
city: Shanghai
country: China
facility: The 85th Hosptial of P.L.A
state: Shanghai
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Zhen Jun Wang, M.D.
role: STUDY_CHAIR
affiliation: Second Affiliated Hospital of Medical College Shandong University
name: Ke Ding, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Anorectal Hospital
name: Chang Shun Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Central Hospital of China Aerospace Corporation
name: Li Yong Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Hebei Province
name: Li Ya Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The 85th Hosptial of P.L.A
name: Min Kong, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Provincial Hospital
name: Xue Zhi Xin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Chao Wen Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenzhen People's Hospital
name: Xiao Dong Yang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Artillery General Hospital
name: Ke Zhao, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dongzhimen Hospital, Beijing
name: Bao Ming Zhao, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Shenyang Anorectal Hospital
name: Xian Dong Zeng, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wuhan Iron and Steel Workers' Hospital
name: Si Tu Guang Wei, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Han JG, Xu HM, Song WL, Jin ML, Gao JS, Wang ZJ, Yang XQ. Histologic analysis of acellular dermal matrix in the treatment of anal fistula in an animal model. J Am Coll Surg. 2009 Jun;208(6):1099-106. doi: 10.1016/j.jamcollsurg.2009.02.052. Epub 2009 Apr 24.
citation: Song WL, Wang ZJ, Zheng Y, Yang XQ, Peng YP. An anorectal fistula treatment with acellular extracellular matrix: a new technique. World J Gastroenterol. 2008 Aug 14;14(30):4791-4. doi: 10.3748/wjg.14.4791.