| CTRI Number |
CTRI/2025/12/098291 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
26/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study comparing two surgical ( karydakis and Gips procedure) in patients with pilonidal sinus disease to see which leads to better healing and fewer wound infections. |
|
Scientific Title of Study
|
Gips Procedure Versus Karydakis Procedure for Pilonidal Sinus Disease: A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sayed Saqib Hussain Shah |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences(AIIMS), VIJAYPUR |
| Address |
Department of General surgery, AIIMS Vijaypur, JAMMU, Jammu & Kashmir
Jammu
JAMMU & KASHMIR
184120
India |
| Phone |
9541356545 |
| Fax |
|
| Email |
sayed.saqib@aiimsjammu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Julie |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences(AIIMS),VIJAYPUR |
| Address |
Department of General surgery, AIIMS Vijaypur, Jammu & Kashmir
Jammu
JAMMU & KASHMIR
184120
India |
| Phone |
7452006081 |
| Fax |
|
| Email |
Julie@aiimsjammu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayed Saqib Hussain Shah |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Vijaypur |
| Address |
Department of General surgery, AIIMS Vijaypur, JAMMU, Jammu & Kashmir
Jammu
JAMMU & KASHMIR
184120
India |
| Phone |
9541356545 |
| Fax |
|
| Email |
sayed.saqib@aiimsjammu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Vijaypur J k |
| Address |
Vijaypur |
| 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 Julie |
AIIMS jammu |
Department of General Surgery, Room No.338,OPD block, AIIMS vijaypur
Jammu
JAMMU & KASHMIR |
7452006081
Julie@aiimsjammu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE,AIIMS JAMMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: L050||Pilonidal cyst and sinus with abscess, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gips procedure |
Minimally invasive trephine procedure for Pilonidal sinus disease as described by Moshe Gips et al. 2008 |
| Comparator Agent |
Karydakis procedure |
Off midline flap closure procedure for pilonidal sinus disease as described by Karydakis in 1973 |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Elective Surgical candidates diagnosed with primary pilonidal sinus disease as per ICD-11
2. Patients consenting to be a part of the study |
|
| ExclusionCriteria |
| Details |
1. Acute Pilonidal abscess
2. Recurrent Pilonidal sinus disease
3. Branching sinus tracts
4. Pregnant female |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome: Time to complete wound healing |
Time to complete wound healing ( measured from the day of surgery to the day of complete epithelialization) assessed at each postoperative visit on day 7th,14th, and one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. wound infection rate as per CDC criteria.
2. postoperative pain using VAS scale
3. Cosmetic outcome using POSAS.
|
POD 1, POD 3, POD 7, 1 month, and 3 months |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
08/12/2025 |
| 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="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This is a prospective randomized controlled trial designed to compare the outcomes of surgical techniques for pilonidal sinus disease: The Gips Procedure and The Karydakis procedure. A total of 86 patients meeting eligibility criteria will be randomly allocated in equal numbers to either groups using block randomization with sealed opaque envelopes. The primary outcome is postoperative wound infection as per CDC criteria. Secondary outcomes include postoperative pain using VAS score, time to complete wound healing, duration of hospital stay, recurrence rate, and cosmetic outcome using POSAS Score. This study aims to determine whether the minimally invasive Gips procedure provides outcomes comparable or superior to the Karydakis flap while mininmizing morbidity. This is in phase III, single center parallel group RCT design. |