FISTULA IN ANONCT07083778
Comparison Between Laser and Open Fistula Surgeries in the Management of Fistula - In - Ano
A study testing Laser Fistula Surgery (FiLaC - Fistula-tract Laser Closure) and Open Fistula Surgery (Fistulotomy, Fistulectomy, or LIFT Procedure) in people with FISTULA IN ANO, run by GSVM Medical College at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- FISTULA IN ANO
- What is being tested?
- Laser Fistula Surgery (FiLaC - Fistula-tract Laser Closure) and Open Fistula Surgery (Fistulotomy, Fistulectomy, or LIFT Procedure)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Apr 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • Pregnant women
- Patients of fistula in ano associated with other conditions(HIV, tubercular disease, IBD, Ca rectum.)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
Primary outcome measures included:
Postoperative pain (VAS score within 7 days)
Duration of hospital stay
Time to resume normal daily activity
Secondary outcomes evaluated were:
Recurrence rate at 3 months
Complete healing within 3 months (closure of both internal and external openings, cessation of discharge)
Anal incontinence rate
Anal stenosis rate
The study intends to assess whether the laser approach offers a meaningful improvement in postoperative morbidity, patient comfort, and quality of life, while also examining risk factors associated with poor surgical outcomes or recurrence.
- Conditions
- FISTULA IN ANO
- Being tested
- Laser Fistula Surgery (FiLaC - Fistula-tract Laser Closure), Open Fistula Surgery (Fistulotomy, Fistulectomy, or LIFT Procedure)
- Keywords
- Fistula-in-ano, Laser fistula surgery, Fistulotomy, Fistulectomy, Postoperative pain, Healing rate, Randomized controlled trial, Recurrence, Incontinence, Intersphincteric fistula, Transsphincteric fistula
- Medical subject headings
- Rectal Fistula, Pain, Postoperative, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Fistula Surgery (FiLaC - Fistula-tract Laser Closure)Procedure or surgery
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)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Laser Surgery Group | Experimental | 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. Receives: Procedure: Laser Fistula Surgery (FiLaC - Fistula-tract Laser Closure) |
| Active Comparator - Open Surgery Group | Active comparator | 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. Receives: Procedure: Open Fistula Surgery (Fistulotomy, Fistulectomy, or LIFT Procedure) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain at 48 Hours
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.
Measured: 48 hours post-surgery
Length of Hospital Stay
Total number of days the patient remains admitted in the hospital from the day of surgery until discharge.
Measured: From day of surgery to discharge (typically within 7 days)
Time to Return to Normal Work
Number of days taken by the patient to resume normal daily activities or work, as self-reported during follow-up visits.
Measured: Within 6 weeks post-surgery
Secondary outcomes (4)
Fistula Recurrence Rate
Proportion of patients showing recurrence of fistula-in-ano after surgery, confirmed clinically or radiologically.
Measured: Between 16 to 20 weeks post-surgery
Time to Complete Healing
Number of days from surgery to complete wound healing, defined as epithelialization of the surgical site without discharge.
Measured: Within 3 months post-surgery
Anal Incontinence Rate (Wexner Score)
Incidence of anal incontinence assessed using the Wexner Incontinence Score, a validated scale ranging from 0 (perfect continence) to 20 (complete incontinence).
Measured: Assessed at each follow-up up to 6 months
Anal Stenosis Rate
Proportion of patients developing clinically significant anal stenosis, defined as narrowing of the anal canal requiring intervention or causing obstructive symptoms.
Measured: Within 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Apr 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FISTULA IN ANOStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective, single-center, randomized controlled trial designed to compare the efficacy and safety of laser ablation (FiLaC technique) versus conventional open surgical techniques (fistulotomy/fistulectomy) in patients diagnosed with intersphincteric or transsphincteric fistula-in-ano. Patients were randomly assigned in a 1:1 ratio to undergo either laser surgery or open surgery after evaluation through clinical examination and MR fistulogram. Both groups were managed as per standard operative protocols and followed up for a period of three months. The study assessed both clinical outcomes and patient-reported outcomes, including postoperative pain (VAS score), duration of hospital stay, time to resume daily activities, healing rate, recurrence, postoperative complications (like incontinence, wound infection), and overall patient satisfaction. This model evaluates the utility of a minimally invasive sphincter-preserving laser technique in comparison to the tradition
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- GSVM Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamal raj, GSVM Medical College
- Investigators
- Kamal Raj, MS surgery, Principal investigator, GSVM MEDICAL COLLEGE , KANPUR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083778
- Sponsor's protocol ID
- GSVM-FIA-RCT-2025-01
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual-level data related to primary and secondary outcomes.
Publications
Patel KR, Jauhari RK, Shukla P. A Randomized Controlled Trial Comparing Laser Versus Open Surgical Approaches in the Management of Fistula-in-Ano at a Tertiary Care Center. Cureus. 2025 Aug 19;17(8):e90471. doi: 10.7759/cureus.90471. eCollection 2025 Aug.
PubMed 40978994
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07083778
- Acronym / sponsor ID
- GSVM-FIA-RCT-2025-01
- Conditions
- FISTULA IN ANO
- Keywords
- Fistula-in-ano, Laser fistula surgery, Fistulotomy, Fistulectomy, Postoperative pain, Healing rate, Randomized controlled trial, Recurrence
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- GSVM Medical CollegeUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Primary outcome measures included:
Postoperative pain (VAS score within 7 days)
Duration of hospital stay
Time to resume normal daily activity
Secondary outcomes evaluated were:
Recurrence rate at 3 months
Complete healing within 3 months (closure of both internal and external openings, cessation of discharge)
Anal incontinence rate
Anal stenosis rate
The study intends to assess whether the laser approach offers a meaningful improvement in postoperative morbidity, patient comfort, and quality of life, while also examining risk factors associated with poor surgical outcomes or recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a prospective, single-center, randomized controlled trial designed to compare the efficacy and safety of laser ablation (FiLaC technique) versus conventional open surgical techniques (fistulotomy/fistulectomy) in patients diagnosed with intersphincteric or transsphincteric fistula-in-ano. Patients were randomly assigned in a 1:1 ratio to undergo either laser surgery or open surgery after evaluation through clinical examination and MR fistulogram. Both groups were managed as per standard operative protocols and followed up for a period of three months. The study assessed both clinical outcomes and patient-reported outcomes, including postoperative pain (VAS score), duration of hospital stay, time to resume daily activities, healing rate, recurrence, postoperative complications (like incontinence, wound infection), and overall patient satisfaction. This model evaluates the utility of a minimally invasive sphincter-preserving laser technique in comparison to the tradition
| Arm | Type | Receives |
|---|---|---|
| Experimental - Laser Surgery Group | Experimental | Procedure: Laser Fistula Surgery (FiLaC - Fistula-tract Laser Closure)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. |
| Active Comparator - Open Surgery Group | Active comparator | Procedure: Open Fistula Surgery (Fistulotomy, Fistulectomy, or LIFT Procedure)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Patient with intersphincter \& transphincter fistula in ano as confirmed by clinical examination followed by MR fistulogram.
Key exclusion criteria (2 listed)
- • Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Experimental - Laser Surgery Group |
| 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. | Procedure or surgery | Active Comparator - Open Surgery Group |
Primary outcome
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.
4 secondary outcomes
Fistula Recurrence Rate
Time frame: Between 16 to 20 weeks post-surgery
Time to Complete Healing
Time frame: Within 3 months post-surgery
Anal Incontinence Rate (Wexner Score)
Time frame: Assessed at each follow-up up to 6 months
Anal Stenosis Rate
Time frame: Within 3 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Derived from this study: PubMed 40978994Patel KR, Jauhari RK, Shukla P. A Randomized Controlled Trial Comparing Laser Versus Open Surgical Approaches in the Management of Fistula-in-Ano at a Tertiary Care Center. Cureus. 2025 Aug 19;17(8):e90471. doi: 10.7759/cureus.90471. eCollection 2025 Aug.
- Individual participant dataSharing planned: Yes. De-identified individual-level data related to primary and secondary outcomes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamal Raj, MS surgery principal investigator
GSVM MEDICAL COLLEGE , KANPUR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Fistula Surgery (FiLaC - Fistula-tract Laser Closure) and Open Fistula Surgery (Fistulotomy, Fistulectomy, or LIFT Procedure) in people with FISTULA IN ANO, run by GSVM Medical College at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain at 48 Hours (time frame: 48 hours post-surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07083778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.