Health TrialsbyHealthPanel

Collagen Paste vs Mucosal Advancement Flap for FIA

ConditionFistula-in-ano
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Collagen Paste

    Procedure/Surgery

    Collagen paste injection

  • Mucosal advancement

    Procedure/Surgery

    Mucosal advancement flap

Treatment groups

118 Participants
are divided into 2 treatment groups
Group A: Collagen PasteExperimental treatment 1 intervention
Group B: Mucosal Advancement FlapActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical healing of Fistula-in-ano

Clinical healing of the fistula-in-ano

Time frame
1 year

Secondary outcomes

1

30-day morbidity

30-day morbidity using Clavien-Dindo classification

Time frame
30 days
2

Quality of life score

Assess effect on Quality of life post operatively using Short Form 36 Health Survey

Time frame
1 year
3

Postoperative pain score

assessment of postoperative pain using visual analog score from 0 (no pain) to 10 (severe pain)

Time frame
1 week
4

Faecal incontinence rate

Assess postoperative effect on continence

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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