Unilateral versus bilateral internal sphincterotomy: a randomised controlled trial for chronic fissure-in-ano

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN60893979

Enrollment

200

Registered

2007-09-24

Start date

2004-01-01

Completion date

Unknown

Last updated

2021-08-17

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

Conditions

Chronic fissure-in-ano Digestive System Chronic anal fissure

Interventions

Group A (active control): single internal lateral sphinterotomy Group B: (new treatment): double internal lateral sphinterotomy A minimum follow up of 6 months.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Disease over one year 2. Aged more than 18 years

Exclusion criteria

Exclusion criteria: 1. Oral medication with nitrates, calcium channel blocker 2. Past ano-rectal surgery 3. Elderly lady with old perineal tear

Design outcomes

Primary

Measure	Time frame
1. Post-operative pain 2. Recurrences	—

Secondary

Measure	Time frame
1. Healing of fissure, measured at 3 to 6 months 2. Incontinence to flatuous and faecal matter, measured from the date of surgery until 6 months in the form of use of pad, soiling of undergarment	—

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026