Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparison Between Laser and Open Fistula Surgeries in the Management of Fistula - In - Ano
Sponsor: GSVM Medical College
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2024-04-01
Completion Date
2025-09-01
Last Updated
2025-07-24
Healthy Volunteers
No
Conditions
Interventions
Laser Fistula Surgery (FiLaC - Fistula-tract Laser Closure)
A minimally invasive procedure using a radial fiber diode laser probe to ablate the fistula tract. Laser energy (10W in pulsed mode) is applied circumferentially as the probe is slowly withdrawn, leading to shrinkage and closure of the fistula tract. The internal opening is closed with absorbable sutures. The procedure is done under spinal or general anesthesia.
Open Fistula Surgery (Fistulotomy, Fistulectomy, or LIFT Procedure)
Patients in this group will undergo standard open surgical treatment for fistula-in-ano. Based on the type and location of the fistula (intersphincteric or transsphincteric), the surgical procedure may be: * Fistulotomy: Laying open the fistula tract. * Fistulectomy: Excision of the entire fistulous tract. * LIFT Procedure: Ligation of the intersphincteric fistula tract, preserving the sphincter complex. This sphincter-sparing technique is chosen for transsphincteric fistulas when appropriate. All procedures are performed under spinal anesthesia. The choice of technique is individualized based on MR fistulogram findings and intraoperative assessment. Wounds are managed with regular dressings and allowed to heal by secondary intention. Standard postoperative care includes antibiotics, analgesia, and sitz baths. Follow-up is done at 1 week, 1 month, 3 months, and 6 months.
Locations (1)
Kamal Raj
Kanpur, Uttar Pradesh, India