Sealing the Gap: An RCT on the Effectiveness of Fibrin Glue to close the Fistula-in-Ano

Sealing the Gap: A Prospective, Randomized Controlled Trial on the Effectiveness of Fibrin Glue in Treating Fistula-in-Ano - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2025/02/080664

Enrollment

Registered

2025-02-17

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: application of fibrin glue on fistulous tract: Fibrin glue is used as sealant agent to close the fistuous tract. cases shall be assessd post operatively at regular periods for closeure

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18-70 with a diagnosed fistula-in-ano. o Eligible for either fibrin glue or standard surgical treatment. o Written informed consent obtained

Exclusion criteria

Exclusion criteria: Complex or high fistulas that are unsuitable for fibrin glue treatment. o Previous treatment for fistula-in-ano within the last 6 months. o Pregnant or breastfeeding women. o Allergies to components of fibrin glue

Design outcomes

Primary

Measure	Time frame
Primary Outcome Complete closure of the fistula assessed at specify time points 3 months and 6 months post- procedure. Secondary Outcomes Recurrence rate defined as the reappearance of the fistula after initial closure. Time to healing, measured from the date of intervention to complete healing. Quality of life, assessed using validated questionnaire (annexure attached) Adverse events, including pain, infection, and incontinenceTimepoint: Closure of tracts shall be assessed at regular intervals like 4 12 18 weeks	—

Measure

Time frame

Primary Outcome Complete closure of the fistula assessed at specify time points 3 months and 6 months post- procedure. Secondary Outcomes Recurrence rate defined as the reappearance of the fistula after initial closure. Time to healing, measured from the date of intervention to complete healing. Quality of life, assessed using validated questionnaire (annexure attached) Adverse events, including pain, infection, and incontinenceTimepoint: Closure of tracts shall be assessed at regular intervals like 4 12 18 weeks

—

Secondary

Measure	Time frame
Recurrence rate is defined as the reappearance of the fistula after initial closure Time to healing measured from the date of intervention to complete healing Quality of life assessed using validated questionnaire Adverse events including pain infection & incontinence Timepoint: Operated cases will be assessed at regular intervals 4 weeks 12 weeks 18 weeks for recurrence rate	—

Countries

India

Contacts

Public ContactDR LAVU JAYANTH

AIIMS MANGALAGIRI

LAVUJAYANTH@AIIMSMANGALAGIRI.EDU.IN9849511547

Outcome results