Fistula in Ano
Conditions
Brief summary
This is a prospective, double-blinded randomised controlled trial conducted at two tertiary hospitals by a credentialed colorectal surgeon.
Detailed description
Patients with high transphincteric fistulas were blinded and randomized to either laser or ligation of the fistula tract (LIFT). Pain scores at rest and movement, at 6 and 24 hours post operatively were measured using the visual analogue scale (VAS). Operative time was measured in minutes Continence and quality of life was assessed via the Wexner incontinence scale and SF-36 questionnaire respectively at 0, 3 and 6 months post-operatively.
Interventions
PROCEDURELaser
Diode laser used to effect closure of the anal fistula tract
PROCEDURELIFT
The intersphincteric portion of the fistula is excised and ligated.
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes assessor was blinded to the intervention.
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Complex transphincteric fistulas: * high transphincteric fistula, involving more than 30% of the external anal sphincter * Multiple fistulas * Anterior fistulas * 18-75 years old * Able to give consent * New or recurrent fistulas * Fistulas with or without setons
Exclusion criteria
* Active perianal sepsis requiring drainage * Fistulas of non-cryptogladular origin- Crohn's, TB, malignancy * Expected lifespan less than 6 months * Pregnant women * Patients with more than 1 definitive surgery done for the fistula before * Patients with human immunodeficiency virus infection * Patients with pre-existing chronic pain disorders * Patients with Non-steroidal Anti-inflammatory Drug (NSAIDS) / Paracetamol allergies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain score | 6 hours, 24 hours | Post-operative pain will be assessed by a blinded assessor using the Visual Analogue Scale (VAS), a validated pain score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continence | At baseline, and at 1 week, 1 month and 6 months post-operatively | The Wexner score was used to assess pre- and post-operative continence. Minimum score is 3, maximum score is 12. The lower the score, the worse the incontinence. |
| SF36 | At baseline, and at 1 week, 1 month and 6 months post-operatively | The SF36 was used to assess pre- and post-operative quality of life. |
| Operative time | Intraoperative | Median operative time was to compare the two arms |
| Duration of analgesia use | Number of days until cessation of analgesia use, assessed at 1 week or 1 month, whichever is shorter | The duration in days that the patient needed to use analgesia post-operative |
| Failure rate | 6 months | Failure to heal was defined as failure of fistula closure (persistent discharge) beyond 6 months' post-operatively |
| Return to work | Number of days taken to return to work, assessed at 6 months post-operatively | Days until return to work |
Countries
Malaysia
Outcome results
None listed