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Clinical Trials/CTRI/2024/05/067579
CTRI/2024/05/067579RecruitingPhase 2

A Comparative Study of Surgical Excision and Steroid Injection in Managing Ganglion Cysts

Saveetha Medical College Hospital1 site in 1 country54 target enrollmentStarted: June 5, 2024Last updated:

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Sponsor
Enrollment
54
Locations
1
Primary Endpoint
complete disappearance of cyst.

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
14.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

complete disappearance of cyst.

Time Frame: 1 week, 1 month, 3months, 6 months

Secondary Outcomes

  • any recurrence(1 month, 3months, 6 months)
  • loss of function(1 month, 3months, 6 months)

Investigators

Sponsor
Saveetha Medical College Hospital
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Karpaka Vinayakam Gopalakrishnan

Saveetha Medical College Hospital

Study Sites (1)

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