Anal Fistula, Perianal Fistula
Conditions
Keywords
Perianal fistula, Anal fistula, Laser ablation, Laser-assisted anal fistula surgery, FiLaC, Fistulectomy, Conventional surgery, Randomized controlled trial
Brief summary
This randomized controlled trial aims to compare conventional open fistulectomy and laser ablation in the treatment of uncomplicated perianal fistula. The study will evaluate postoperative recovery time and recurrence rates between the two procedures. A total of 72 patients with uncomplicated perianal fistula will be randomly assigned to either conventional open fistulectomy or laser ablation and followed for six months after surgery.
Detailed description
Perianal fistula is a common anorectal condition that usually requires surgical treatment. Conventional open fistulectomy has been widely used because of its established effectiveness; however, it may be associated with prolonged recovery. Laser-assisted anal fistula surgery is a newer minimally invasive technique that may offer faster postoperative recovery and less tissue damage. Published studies have reported conflicting results regarding the superiority of either technique in terms of postoperative recovery and recurrence. Therefore, this randomized controlled trial is being conducted to compare conventional open fistulectomy and laser ablation in patients with uncomplicated perianal fistula. The study will be conducted at the Department of Surgery, PNS Hafeez Hospital, Islamabad. Seventy-two patients aged 18 to 55 years with uncomplicated perianal fistula will be enrolled and randomized in a 1:1 ratio by paper lottery method into two groups. Group C will undergo conventional open fistulectomy, and Group L will undergo laser-assisted anal fistula surgery. The primary outcome measures are postoperative recovery time and recurrence of perianal fistula within six months after surgery. Patients will be followed at two weeks and six months postoperatively. The findings of this study may help determine the optimal surgical approach for uncomplicated perianal fistula.
Interventions
PROCEDURELaser ablation
Laser-assisted anal fistula surgery for uncomplicated perianal fistula.
PROCEDUREConventional Open Fistulectomy
Conventional open fistulectomy for uncomplicated perianal fistula.
Sponsors
PNS Hafeez - Naval Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomized in a 1:1 ratio to either conventional open fistulectomy or laser-assisted anal fistula surgery and followed prospectively.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 to 55 years. * Male and female patients. * Scheduled for surgical treatment of uncomplicated perianal fistula. * Single fistula tract. * Less than 30% involvement of the external anal sphincter. * Penetration of tract limited to subcutaneous tissue.
Exclusion criteria
* Recurrent fistula. * Complex fistula. * History of gut malignancy. * History of inflammatory bowel disease. * Patients unfit for anesthesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative recovery time | 2 weeks after surgery | Time from the end of surgery until return to work with no residual anal pain and no bleeding or discharge. |
| Recurrance of perianal fistula | 6 months after surgery | Reappearance of perianal fistula after surgery. |
Countries
Pakistan
Contacts
CONTACTFahad Raza Ansari, MBBS, FCPS Resident
Outcome results
None listed