| CTRI Number |
CTRI/2025/07/092120 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
LASER CLOSURE VS LIMBERG FLAP IN THE MANAGEMENT OF PILONIDAL DISEASE |
|
Scientific Title of Study
|
SINUS LASER CLOSURE SILAC VS LIMBERG FLAP IN THE MANAGEMENT OF PILONIDAL DISEASE : A RANDOMISED COMPARATIVE STUDY |
| Trial Acronym |
Sinus, laser, limberg , pilonidal |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SATPAL CHAHAR |
| Designation |
Post graduate |
| Affiliation |
BASE HOSPITAL & ARMY COLLEGE OF MEDICAL SCIENCES DELHI CANTT |
| Address |
BASE HOSPITAL & ARMY COLLEGE OF MEDICAL SCIENCES DELHI CANTT
Surgery department
New Delhi
DELHI
110010
India |
| Phone |
8285634608 |
| Fax |
|
| Email |
satpalchahar29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NAYAN SHARMA |
| Designation |
Guide |
| Affiliation |
BASE HOSPITAL & ARMY COLLEGE OF MEDICAL SCIENCES DELHI CANTT |
| Address |
Surgery department, BASE HOSPITAL & ARMY COLLEGE OF MEDICAL SCIENCES DELHI CANTT
New Delhi
DELHI
110010
India |
| Phone |
8527261555 |
| Fax |
|
| Email |
nayan_afmc@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr SATPAL CHAHAR |
| Designation |
Post graduate |
| Affiliation |
BASE HOSPITAL & ARMY COLLEGE OF MEDICAL SCIENCES DELHI CANTT |
| Address |
BASE HOSPITAL & ARMY COLLEGE OF MEDICAL SCIENCES DELHI CANTT
Surgery department
New Delhi
DELHI
110010
India |
| Phone |
8285634608 |
| Fax |
|
| Email |
satpalchahar29@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
BASE HOSPITAL |
| Address |
BASE HOSPITAL & ARMY COLLEGE OF MEDICAL SCIENCEs DELHI CANTT, surgery department, pincode 110010 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SATPAL CHAHAR |
surgery department |
BASE HOSPITAL & ARMY COLLEGE OF MEDICAL SCIENCES, DELHI CANTT
South West
DELHI |
8285634608
satpalchahar29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee base hospital &army college of medical sciences Delhi cantt |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LIMBERG flap vs SiLAC |
LIMBERG flap is a technique using rhomboid excision with tension free closure, SiLAC is laser based surgery. The primary and secondary objectives will be analysed upto 3 months post surgery |
| Intervention |
Pilonidal sinus |
An abnormal skin growth located at the tailbone that contains hair and skin.
The cyst is usually located near the tailbone and can become easily infected.
Symptoms of an infected cyst include pain, reddened skin or drainage of pus or blood. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with pilonidal disease,
Patient deemed suitable for either sinus laser or LIMBERG flap surgery |
|
| ExclusionCriteria |
| Details |
Unwilling patients, active infection or abscess at pilonidal site, undergoing medical illnesses, previous pilonidal disease surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the effectiveness of SILAC and LIMBERG FLAP in terms of healing and recurrence rates. |
Post operative day 1, 2 weeks, 1 and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the safety of both surgeries by assessing complication rates, compare pain levels,recovery time and satisfaction, compare operative time and length of hospital stay. |
Post operative at 1 day, 2 weeks, 1 month, 3 months |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
SINUS LASER CLOSURE SILAC VS LIMBERG FLAP IN THE MANAGEMENT OF PILONIDAL DISEASE : A RANDOMISED COMPARATIVE STUDY |