Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06386835
Other study ID # CREC2021.724-T
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 26, 2024
Est. completion date March 31, 2027

Study information

Verified date April 2024
Source Chinese University of Hong Kong
Contact Kaori Futaba, FRCS
Phone 35051495
Email kfutaba@surgery.cuhk.edu.hk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The treatment for fistula-in-ano (FIA) remains a challenge to General and Colorectal Surgeons Worldwide. A variety of surgical treatments have been described for high anal fistulas, but none offers the panacea of fistula eradication with guaranteed preservation of continence. This study compares Collagen paste injection to mucosal advancement flap for the treatment of fistula-in-ano.


Description:

Rectal advancement flaps have been advocated as a means of closing high fistulas with preservation of the external sphincter muscle. With this technique, it shows promising results with success rate of approximately 60%. However, complications have been reported, in particular with a change of continence in 30-35% of patients. Collagen paste is a novel sphincter-preserving method for fistula closure. Permacol (Medtronic, USA) is a sterile acellular cross-linked porcine dermal collagen matrix suspension. The paste-like suspension form a matrix that accelerates neovascularization, cellular infiltration which promotes healing and fistula closure. The theoretical benefits of paste form compared to previous collagen plug design is that the collagen can moulded into the fistula cavity or tract. This allows better tissue contact with the collagen thus improves healing and reduces the chance of dislodgement. Limited data is available to date. Success rates of collagen paste range from 47.6% to 63%. Hence it has a potential to be the first-line treatment for high FIA with low complication rates and without causing disruption to the anal sphincter complex.


Recruitment information / eligibility

Status Recruiting
Enrollment 118
Est. completion date March 31, 2027
Est. primary completion date March 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Clinical diagnosis of high cryptoglandular fistula-in-ano. - Patients must have undergone a prior EUA to characterise the nature of the fistula. - The fistula tract should be = 2 cm in length. - Only a single internal fistula opening should be present at EUA, such that the fistula is suitable for treatment by insertion of a seton drain. - Patients must have been treated with a draining seton for a minimum period of 6 weeks prior to randomisation. - Patients must be aged = 18 years and able to provide informed consent. - Fistulas must be of cryptoglandular aetiology. Exclusion Criteria: - Unable/unwilling to provide informed consent. - Contraindication to general anaesthesia or spinal anaesthesia. - Low trans-sphincteric fistulas. - Non-cryptoglandular fistulas (e.g. Crohn's disease, obstetric, irradiation, malignant, etc.). - Other perineal fistulas (e.g. rectovaginal fistulas, pouch-vaginal fistulas, etc.). - Complex disease in which more than one internal fistula opening is present and requiring concurrent insertion of more than one fistula plug. - Clinical evidence of active perianal sepsis. In the event that there is disagreement between clinical and radiological assessment of active sepsis/collection, the clinical opinion will prevail. - Cultural or religious objection to the use of pig tissue. - Absolute contraindication to magnetic resonance imaging (MRI) (e.g. cardiac pacemaker). - Patients with recurrent anal fistulas previously treated with a fistula plug.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Collagen Paste
Collagen paste injection
Mucosal advancement
Mucosal advancement flap

Locations

Country Name City State
Hong Kong Prince of Wlaes Hospital Sha Tin
Hong Kong Department of Surgery, Chinese University of Hong Kong Shatin New Territories

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical healing of Fistula-in-ano Clinical healing of the fistula-in-ano 1 year
Secondary 30-day morbidity 30-day morbidity using Clavien-Dindo classification 30 days
Secondary Quality of life score Assess effect on Quality of life post operatively using Short Form 36 Health Survey 1 year
Secondary Postoperative pain score assessment of postoperative pain using visual analog score from 0 (no pain) to 10 (severe pain) 1 week
Secondary Faecal incontinence rate Assess postoperative effect on continence 1 year
Secondary Hospital readmission rate Assess hospital re-admission rate 1 year
See also
  Status Clinical Trial Phase
Suspended NCT03017898 - Treatment of Anal Fistula With Lasercoagulation N/A
Not yet recruiting NCT02579330 - Trial on Use of Coloshield in Transanal and Anal Surgery N/A