| CTRI Number |
CTRI/2024/05/067579 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing Surgery and steroids for Ganglion Cysts: What Works Best? |
|
Scientific Title of Study
|
A Comparative Study of Surgical Excision and Steroid Injection in Managing Ganglion Cysts |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karpaka Vinayakam Gopalakrishnan |
| Designation |
UG student |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
Department Of General Surgery, Unit 7, ROOM: IC4, Saveetha Medical College Hospital Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
6380751321 |
| Fax |
|
| Email |
karpaka36@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KAWUSHIK KUMAR P |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
IC3, Department of General Surgery, Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105
Chennai
TAMIL NADU
602105
India |
| Phone |
9597037959 |
| Fax |
|
| Email |
kawushikkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KAWUSHIK KUMAR P |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Saveetha Medical College Hospital |
| Address |
IC3, Department of General Surgery, Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105
TAMIL NADU
602105
India |
| Phone |
9597037959 |
| Fax |
|
| Email |
kawushikkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College And Hospital |
|
|
Primary Sponsor
|
| Name |
Saveetha Medical College Hospital |
| Address |
Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 KAWUSHIK KUMAR |
Saveetha Medical College Hospital |
IC4, Department of General Surgery, Saveetha Medical College Hospital, Saveetha Nagar, Thandalam, Chennai Bengaluru, NH 48, Chennai, Tamil Nadu 602105
Chennai
TAMIL NADU |
6380751321
kawushikkumar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intralesional steroidal injection |
the area will be first locally infiltrated with 10 ml of 2% lignocaine, and then using an 18 G syringe the cyst will be first aspirated, and then a similar 18 G pre-filled syringe containing 40 mg of triamcinolone acetate will be used to inject the steroid into the lesion. it is administered once, intracystically at a dose of 40mg |
| Intervention |
Surgical Excision |
Initially, 10 ml of 2% lignocaine, a local anesthetic, will be injected locally. The surgical procedure will involve removing the pedicle in addition to the entire cyst complex, and the surgical site will be approximated using a 3-0 ethilon. Postoperatively, the patient will be immobilized using a plaster of Paris (POP) slab |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who were older than 14 years, without a history of therapy for ganglion who had a clinical diagnosis of ganglion cysts with a size greater than 1 cm, and willingness to follow up will be included in the study |
|
| ExclusionCriteria |
| Details |
patients who were not willing to follow-up or did not provide consent to this study and those who had any concurrent medical conditions that could affect the joints or tendons will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| complete disappearance of cyst. |
1 week, 1 month, 3months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| any recurrence |
1 month, 3months, 6 months |
| loss of function |
1 month, 3months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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 2 |
|
Date of First Enrollment (India)
|
05/06/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Ganglion cysts are benign soft tissue tumors that commonly occur in the joints, especially the wrist. Surgical excision and steroid injection are the two main treatment options; however, their efficacy remains unclear. This prospective interventional control trial will include 54 patients with ganglion cysts.Patients were divided into two groups: Group A under going surgical excision and Group B in whom aspiration will be followed by 40 mg of intralesional triamcinolone acetonide injection. A follow-up session will be scheduled at 1 week, 1 month, 3 months, and 6 months after the intervention will be performed, during which time they will be assessed for recurrence and postoperative complications.
|