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Anal Fistula Plug for High-type Anal Fistulae

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ClinicalTrials.gov Identifier: NCT00487071
Recruitment Status : Terminated (No financial support)
First Posted : June 15, 2007
Last Update Posted : February 13, 2014
Sponsor:
Information provided by (Responsible Party):
Simon S. M. Ng, Chinese University of Hong Kong

Study Description
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Brief Summary:
The aim of this pilot study is to evaluate the efficacy and safety of anal fistula plug in the management of high-type anal fistulae among Hong Kong Chinese patients.

Condition or disease Intervention/treatment Phase
High-type Anal Fistulae Device: Anal fistula plug Not Applicable

Detailed Description:

An anal fistula is an abnormal communication between the anal or rectal lumen and the perianal skin. Anal fistulae are described according to the level at which they transgress the anal sphincter. If the internal opening begins above the anal sphincter then the fistula is described as 'high'. Traditional surgery for high-type anal fistulae often requires staged operations with fistulotomy and seton insertion. The surgery usually results in large and deep wounds which can take months to heal. Moreover, risk of faecal incontinence is inevitable because part of the anal sphincter is divided during the surgery.

The Surgisis® anal fistula plug is a minimally invasive and sphincter-preserving alternative to traditional fistula surgery. It is a newly developed biomaterial made from complex collagen obtained from pigs - animals that have a collagen structure almost identical to that of human tissue. During manufacturing of the plug, living cells are removed by special processes to help ensure that no transmittable diseases are present in the tissue. The plug is a conical device and is placed by drawing it through the fistula tract and suturing it in place. As pig collagen is so similar to human collagen, the plug, once implanted, incorporates naturally over time into the human tissue (human cells and tissues will 'grow' into the plug), thus facilitating the closure of the fistula. Preliminary clinical data from USA showed a high fistula closure rate of 87%. The anal fistula plug can also avoid protracted postoperative wound care and minimise the risk of faecal incontinence.

We would like to carry out a pilot study, the aim of which is to evaluate the efficacy and safety of this new anal fistula plug in the management of high-type anal fistulae. This is believed to be the first study of its kind in Hong Kong.

Patients with high-type anal fistulae confirmed by MRI will be recruited into this study. Patients with previous history of fistula surgery, patients with Crohn's disease, and patients with known allergy to porcine material will be excluded. EUA + anal fistula plug will be performed. Outcome measures include fistula healing rate, recurrence rate, and morbidity. Follow-up MRI will be arranged at 3 months and 6 months after the operation to objectively evaluate the healing of the fistulae.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Anal Fistula Plug in the Management of High-type Anal Fistulae: a Pilot Study
Study Start Date : August 2006
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arms and Interventions
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Arm Intervention/treatment
Experimental: Anal fistula plug Device: Anal fistula plug


Outcome Measures
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Primary Outcome Measures :
  1. Fistula healing rate and time for fistula closure [ Time Frame: Up to 1 year ]

Secondary Outcome Measures :
  1. Fistula recurrence rate [ Time Frame: Up to 1 year ]
  2. Morbidity [ Time Frame: Up to 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with high-type anal fistulae confirmed by MRI
  • Informed consent available

Exclusion Criteria:

  • Patients with previous fistula surgery
  • Patients with Crohn's disease
  • Patients allergic to porcine material
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00487071


Locations
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China
Department of Surgery, Prince of Wales Hospital
Hong Kong SAR, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Simon SM Ng, FRCSEd (Gen) Chinese University of Hong Kong
More Information
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Responsible Party: Simon S. M. Ng, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00487071    
Other Study ID Numbers: CRE-2006.274
First Posted: June 15, 2007    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014
Keywords provided by Simon S. M. Ng, Chinese University of Hong Kong:
Anal fistula
High-type
Anal fistula plug
Efficacy
Recurrence
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
 Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases