Perianal FistulaNCT07681531
Laser Ablation Versus Conventional Fistulectomy for Uncomplicated Perianal Fistula
A study testing Laser ablation and Conventional Open Fistulectomy in people with Perianal Fistula and Anal Fistula, run by PNS Hafeez - Naval Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Perianal Fistula, Anal Fistula
- What is being tested?
- Laser ablation and Conventional Open Fistulectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2026to 31 Mar 2027
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Recurrent fistula.
- Complex fistula.
- History of gut malignancy.
- History of inflammatory bowel disease.
- Patients unfit for anesthesia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
PNS Hafeez Naval Hospital
Islamabad, 44400
Fahad Raza Ansari, MBBS, FCPS Resident, +923215550121, sunny_slf@hotmail.com
About this study
Official title: Comparison Between Conventional Surgery and Laser Ablation for Uncomplicated Perianal Fistula
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.
Read the 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.
- Conditions
- Perianal Fistula, Anal Fistula
- Being tested
- Laser ablation, Conventional Open Fistulectomy
- Keywords
- Perianal fistula, Anal fistula, Laser ablation, Laser-assisted anal fistula surgery, FiLaC, Fistulectomy, Conventional surgery, Randomized controlled trial
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser ablationProcedure or surgery
Laser-assisted anal fistula surgery for uncomplicated perianal fistula.
Conventional Open FistulectomyProcedure or surgery
Conventional open fistulectomy for uncomplicated perianal fistula.
| Study group | Role | What they receive |
|---|---|---|
| Laser Ablation | Experimental | Patients will undergo laser-assisted anal fistula surgery according to institutional protocol. Receives: Procedure: Laser ablation; Procedure: Conventional Open Fistulectomy |
| Conventional Open Fistulectomy | Active comparator | Patients will undergo conventional open fistulectomy according to institutional protocol. Receives: Procedure: Laser ablation; Procedure: Conventional Open Fistulectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative recovery time
Time from the end of surgery until return to work with no residual anal pain and no bleeding or discharge.
Measured: 2 weeks after surgery
Recurrance of perianal fistula
Reappearance of perianal fistula after surgery.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal FistulaStudies 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
- Participants will be randomized in a 1:1 ratio to either conventional open fistulectomy or laser-assisted anal fistula surgery and followed prospectively.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PNS Hafeez - Naval Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fahad Raza Ansari, PNS Hafeez - Naval Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681531
- Sponsor's protocol ID
- 491/28 dated 10 July 2025
- Status last verified
- Jun 2026
- First submitted
- 26 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators have not yet determined whether de-identified individual participant data will be shared with other researchers. Any future data sharing will be subject to institutional policies, ethical approval, and participant confidentiality requirements.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Conventional Surgery and Laser Ablation for Uncomplicated Perianal Fistula
- ClinicalTrials.gov ID
- NCT07681531
- Acronym / sponsor ID
- 491/28 dated 10 July 2025
- Conditions
- Perianal Fistula, Anal Fistula
- Keywords
- Perianal fistula, Anal fistula, Laser ablation, Laser-assisted anal fistula surgery, FiLaC, Fistulectomy, Conventional surgery, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- PNS Hafeez - Naval HospitalOther government
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 Jul 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Laser Ablation | Experimental | Procedure: Laser ablation, Procedure: Conventional Open FistulectomyPatients will undergo laser-assisted anal fistula surgery according to institutional protocol. |
| Conventional Open Fistulectomy | Active comparator | Procedure: Laser ablation, Procedure: Conventional Open FistulectomyPatients will undergo conventional open fistulectomy according to institutional protocol. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- Recurrent fistula.
- Complex fistula.
- History of gut malignancy.
- History of inflammatory bowel disease.
- Patients unfit for anesthesia.
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 ablationLaser-assisted anal fistula surgery for uncomplicated perianal fistula. | Procedure or surgery | Conventional Open Fistulectomy, Laser Ablation |
| Conventional Open FistulectomyConventional open fistulectomy for uncomplicated perianal fistula. | Procedure or surgery | Conventional Open Fistulectomy, Laser Ablation |
Primary outcome
Post operative recovery time
Time frame: 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
Time frame: 6 months after surgery
Reappearance of perianal fistula after 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 2 Jul 2026.
- Individual participant dataSharing planned: Undecided. The investigators have not yet determined whether de-identified individual participant data will be shared with other researchers. Any future data sharing will be subject to institutional policies, ethical approval, and participant confidentiality requirements.
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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.
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 ablation and Conventional Open Fistulectomy in people with Perianal Fistula and Anal Fistula, run by PNS Hafeez - Naval Hospital at 1 site in Pakistan.
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 6 inclusion and 5 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: opening soon, as of the sponsor's last update on 2 Jul 2026. 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 Pakistan. 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?
Contact Fahad Raza Ansari, MBBS, FCPS Resident (+923215550121, sunny_slf@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative recovery time (time frame: 2 weeks after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2026.