A Randomized Controlled Trial to Determine the Efficacy and Safety of Laser Versus Open Surgery in the Treatment of Fistula-in-Ano at a Tertiary Care Centre
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Postoperative Pain at 48 Hours
Study Overview
Brief Summary
This prospective randomized controlled trial compared the outcomes of laser versus open surgical techniques in the management of fistula-in-ano among 100 patients at a tertiary care center. Patients were diagnosed with intersphincteric or transsphincteric fistulas using clinical examination and MR fistulogram and were randomly assigned to undergo either laser surgery (n=50) or open surgery (n=50).
The primary endpoints included postoperative pain, hospital stay duration, and time to return to normal activity. Secondary outcomes assessed were recurrence, wound infection, incontinence, need for reoperation, and patient satisfaction.
Detailed Description
This is a prospective, randomized, open-label, parallel-group interventional clinical trial conducted at GSVM Medical College, Kanpur, aimed at comparing the clinical efficacy and safety of laser surgery using the FiLaC (Fistula Laser Closure) technique versus conventional open surgical procedures (fistulotomy or fistulectomy) in the management of fistula-in-ano.
A total of 100 adult patients (>18 years), with a confirmed diagnosis of intersphincteric or transsphincteric fistula-in-ano based on clinical evaluation and magnetic resonance (MR) fistulogram, were enrolled. Following informed consent and screening, patients were randomized in a 1:1 ratio into two arms:
Group A (Laser Surgery Group): Underwent minimally invasive FiLaC procedure using a 1470 nm diode laser and radial fiber probe for endofistular ablation.
Group B (Open Surgery Group): Underwent traditional open surgical procedures including fistulotomy, fistulectomy, or LIFT (Ligation of Intersphincteric Fistula Tract), depending on fistula anatomy.
All surgeries were performed under spinal anesthesia. Postoperative care was standardized across both groups. Patients were followed for a minimum of 3 months with structured clinical assessments at regular intervals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •• Patient with intersphincter & transphincter fistula in ano as confirmed by clinical examination followed by MR fistulogram.
- •Age 18 to 65 years
- •Non responders and Recurrent Patient giving written informed consent of selected fistula surgery and having awareness about alternative procedures.
Exclusion Criteria
- •• Pregnant women
- •Patients of fistula in ano associated with other conditions(HIV, tubercular disease, IBD, Ca rectum.)
Arms & Interventions
Experimental - Laser Surgery Group
Patients randomized to this arm will undergo laser ablation of the fistula tract using a radial fiber laser probe (e.g., FiLaC technique). The procedure is performed under spinal or general anesthesia. The internal opening is closed, and laser energy (10W in pulsed mode) is delivered circumferentially along the fistula tract to ablate it.
All patients will receive standard perioperative care, including IV antibiotics preoperatively and oral antibiotics postoperatively.
Intervention: Laser Fistula Surgery (FiLaC - Fistula-tract Laser Closure) (Procedure)
Active Comparator - Open Surgery Group
Patients randomized to this arm will undergo standard open surgery (fistulotomy or fistulectomy or LIFT ), depending on the anatomy of the fistula. The tract will be laid open or excised under spinal anesthesia. Wounds will be left to heal by secondary intention.
Standard postoperative care includes oral antibiotics, analgesia, sitz baths, and regular dressings.
Intervention: Open Fistula Surgery (Fistulotomy, Fistulectomy, or LIFT Procedure) (Procedure)
Outcomes
Primary Outcomes
Postoperative Pain at 48 Hours
Time Frame: 48 hours post-surgery
Assessment of postoperative pain using the Visual Analogue Scale (VAS) scored from 0 (no pain) to 10 (worst pain imaginable), recorded at 48 hours after surgery.
Length of Hospital Stay
Time Frame: From day of surgery to discharge (typically within 7 days)
Total number of days the patient remains admitted in the hospital from the day of surgery until discharge.
Time to Return to Normal Work
Time Frame: Within 6 weeks post-surgery
Number of days taken by the patient to resume normal daily activities or work, as self-reported during follow-up visits.
Secondary Outcomes
- Fistula Recurrence Rate(Between 16 to 20 weeks post-surgery)
- Time to Complete Healing(Within 3 months post-surgery)
- Anal Incontinence Rate (Wexner Score)(Assessed at each follow-up up to 6 months)
- Anal Stenosis Rate(Within 3 months post-surgery)
Investigators
Kamal raj
Junior Resident , Department of general Surgery
GSVM Medical College