NCT06386835

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Jan 2024Mar 2027

Study Start

First participant enrolled

January 26, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 26, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Expected
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

2.2 years

First QC Date

April 22, 2024

Last Update Submit

April 24, 2024

Conditions

Fistula-in-ano

Outcome Measures

Primary Outcomes (1)

  • Clinical healing of Fistula-in-ano

    Clinical healing of the fistula-in-ano

    1 year

Secondary Outcomes (5)

  • 30-day morbidity

    30 days

  • Quality of life score

    1 year

  • Postoperative pain score

    1 week

  • Faecal incontinence rate

    1 year

  • Hospital readmission rate

    1 year

Study Arms (2)

Collagen Paste

EXPERIMENTAL

Seton is removed, the fistula tract is de-epithelialised and collagen paste applied.

Procedure: Collagen Paste

Mucosal Advancement Flap

ACTIVE COMPARATOR

The internal opening is excised and is covered with a "U-shape" rectal mucosal flap

Procedure: Mucosal advancement

Interventions

Collagen PastePROCEDURE

Collagen paste injection

Collagen Paste
Mucosal advancementPROCEDURE

Mucosal advancement flap

Mucosal Advancement Flap

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Surgery, Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

RECRUITING

Prince of Wlaes Hospital

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Kaori Futaba, FRCS

CONTACT

35051495kfutaba@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 22, 2024

First Posted

April 26, 2024

Study Start

January 26, 2024

Primary Completion

March 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations

HK(2)