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

History of Changes

Purpose

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	Intervention
High-type Anal Fistulae	Device: Anal fistula plug


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Efficacy of Anal Fistula Plug in the Management of High-type Anal Fistulae: a Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Fistulas

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

Fistula healing rate and time for fistula closure [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]


Enrollment:	10
Study Start Date:	August 2006
Study Completion Date:	February 2014
Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Anal fistula plug	Device: Anal fistula plug

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00487071

Locations


China
Department of Surgery, Prince of Wales Hospital
Hong Kong SAR, China

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators


Principal Investigator:	Simon SM Ng, FRCSEd (Gen)	Chinese University of Hong Kong

More Information

No publications provided


Responsible Party:	Simon S. M. Ng, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00487071 History of Changes
Other Study ID Numbers:	CRE-2006.274
Study First Received:	June 13, 2007
Last Updated:	February 12, 2014
Health Authority:	Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:


Anal fistula High-type Anal fistula plug Efficacy Recurrence

Additional relevant MeSH terms:


Fistula Rectal Fistula Digestive System Diseases Digestive System Fistula Gastrointestinal Diseases	Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Rectal Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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