Anal Fistula Plug for High-type Anal Fistulae

This study has been terminated.
(No financial support)
Sponsor:
Information provided by (Responsible Party):
Simon S. M. Ng, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00487071
First received: June 13, 2007
Last updated: February 12, 2014
Last verified: February 2014

June 13, 2007
February 12, 2014
August 2006
February 2014   (final data collection date for primary outcome measure)
Fistula healing rate and time for fistula closure [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
Fistula healing rate and time for fistula closure
Complete list of historical versions of study NCT00487071 on ClinicalTrials.gov Archive Site
  • Fistula recurrence rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
  • Morbidity [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
  • Fistula recurrence rate
  • Morbidity
Not Provided
Not Provided
 
Anal Fistula Plug for High-type Anal Fistulae
Efficacy of Anal Fistula Plug in the Management of High-type Anal Fistulae: a Pilot Study

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
High-type Anal Fistulae
Device: Anal fistula plug
Experimental: Anal fistula plug
Intervention: Device: Anal fistula plug
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00487071
CRE-2006.274
Yes
Simon S. M. Ng, Chinese University of Hong Kong
Chinese University of Hong Kong
Not Provided
Principal Investigator: Simon SM Ng, FRCSEd (Gen) Chinese University of Hong Kong
Chinese University of Hong Kong
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP