To compare the outcomes between Fistula LASER Closure and Fistulotomy/ Fistulectomy and Ligation of Inter-sphincteric Fistula Tract for the treatment of Fistula in Ano
Design
Pragmatic, community based, parallel group of 150 patients, not blinded, randomised controlled trial
Settings and conduct
Trial is not blinded.
A total of 150 patients with primary anal fistula will be included. Group 1 will undergo FILAC and group 2 will undergo open procedure for treatment. Patients will be followed for a period of 3 months after the surgical procedure to compare outcomes between 2 groups. Each patient will be assessed for healing time, anal incontinence, recurrence and satisfaction level.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1. Patients who are ≥ 18 years and ≤60 years and are able to process the information and give informed consent
2. Patients reporting to General Surgical OPD with Primary Perianal Fistula, reporting first time with symptoms and confirmed through digital rectal examination.
3. Patients who are ASA I and ASA II
Exclusion Criteria:
1. Patients with anal incontinence
2. Patients with secondary causes of perianal fistula like tuberculosis, diabetes mellitus, inflammatory bowel disease, candidiasis and hidradenitis suppurativa
3. Patients who already underwent any perianal procedure
Intervention groups
A total of 150 patients will be included in the study as per sample size.
Patients will be divided into 2 groups based on surgical procedure performed. Each group will contain 75 patients.
Group 1 will undergo FILAC (LASER closure) and group 2 will undergo open procedure of fistulectomy/ fistulotomy/ Ligation of inter-sphincteric tract for perianal fistula treatment.
Main outcome variables
Outcomes will be determined by following variables:
1. Wound Healing Time
2. Anal Incontinence
3. Recurrence
4. Patient satisfaction level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260820070737N1
Registration date:2026-08-26, 1405/06/04
Registration timing:prospective
Last update:2026-08-26, 1405/06/04
Update count:0
Registration date
2026-08-26, 1405/06/04
Registrant information
Name
Mahrukh Alam
Name of organization / entity
College of Physicians and Surgeons Pakistan
Country
Pakistan
Phone
+92 300 9189660
Email address
mahrukhalam_06@yahoo.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-10-01, 1405/07/09
Expected recruitment end date
2027-04-01, 1406/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative outcomes of fistula LASER closure and open techniques in Fistula in Ano treatment
Public title
Fistula LASER closure in Fistula in Ano
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients reporting to General Surgical OPD with Primary Perianal Fistula, reporting first time with symptoms and confirmed through digital rectal examination
Patients who are ASA I and ASA II
Patients who are able to process the information and give informed consent
Exclusion criteria:
Patients with anal incontinence
Patients with secondary causes of perianal fistula like tuberculosis, diabetes mellitus, inflammatory bowel disease, candidiasis and hidradenitis suppurativa
Patients who already underwent any perianal procedure
Age
From 18 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee/ Institutional review board of combined military hospital rawalpindi
Street address
Tamiz Ud Din Road, Rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2026-05-19, 1405/02/29
Ethics committee reference number
1026
Health conditions studied
1
Description of health condition studied
Patients reporting to General Surgical OPD with Primary Perianal Fistula, reporting first time with symptoms and confirmed through digital rectal examination
ICD-10 code
K60.3
ICD-10 code description
Anal fistula
Primary outcomes
1
Description
Recurrence
Timepoint
1 month after the intervention
Method of measurement
It will be assessed by occurrence of symptoms of perianal fistula after the symptom free period of at least one month once surgical treatment is given
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group 1 will undergo FILAC
Category
Treatment - Surgery
2
Description
Intervention group: Group 2 will undergo open procedure of fistulectomy/ fistulotomy/ Ligation of inter-sphincteric tract for perianal fistula treatment
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
General Surgery OPD of Combined Military Hospital Rawalpindi
Full name of responsible person
Mahrukh Alam
Street address
Tamiz Ud Din Road Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 300 9189660
Email
mahrukhalam_06@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
PI initiated (personal)
Full name of responsible person
Mahrukh Alam
Street address
Tamiz Ud Din Road Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 300 9189660
Email
mahrukhalam_06@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Combined Military Hospital Rawalpindi
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
College of Physicians and Surgeons Pakistan
Full name of responsible person
Mahrukh Alam
Position
Post Graduate
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Tamiz Ud Din Road Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 300 9189660
Email
mahrukhalam_06@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
College of Physicians and Surgeons Pakistan
Full name of responsible person
Mahrukh Alam
Position
Post Graduate
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Tamiz Ud Din Road Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 300 9189660
Email
mahrukhalam_06@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
College of Physicians and Surgeons Pakistan
Full name of responsible person
Mahrukh Alam
Position
Post graduate
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
Tamiz Ud Din Road Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 300 9189660
Email
mahrukhalam_06@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD