Ganglion Resection Effectiveness Trial (GangLion)

Tampere University Hospital

Status: Enrolling

Conditions: Wrist Ganglion; Connective Tissue Disease; Ganglion; Ganglion Cyst; Mucinoses

Treatments: Other: Conservative treatment; Procedure: Open resection; Procedure: Arthroscopic resection

Study type: Interventional

Funder types: Other

Identifiers

NCT07162415

R25038

Details and patient eligibility

About

The goal of this clinical trial is to learn if surgery helps with wrist ganglions in adults. The main question it aims to answer is:

• Does surgery result in better patient-reported outcomes and satisfaction over a 6-months follow-up period?

Researchers will compare surgery to conservative treatment (self-administered exercises and use of the hand as tolerated) to see if surgery provides superior outcomes.

Participants will:

• Be randomly assigned to receive either surgery or conservative treatment
• Complete questionnaires about wrist pain, function, quality of life, satisfaction, and recovery at 3, 6, and 12 months

Full description

Wrist ganglions are the most common soft tissue tumors of the hand and also the most frequently excised hand lesions. Despite their high prevalence, the best treatment remains uncertain, as earlier studies have provided conflicting evidence and randomized controlled data are scarce.

This study is a multicenter, randomized, controlled, superiority trial comparing surgical excision with conservative care in adults with a painful wrist ganglion. The trial is conducted in Finland and Singapore, with participants randomized in equal groups. Follow-up continues for 12 months, with primary evaluation at 6 months.

The study protocol has been reviewed and approved by the regional ethics committee. Written informed consent will be obtained from all participants prior to enrollment. Results will be published in peer-reviewed journals and presented at scientific meetings to inform clinical decision-making for patients with wrist ganglions.

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• wrist pain located in the ganglion area
• diagnosis of ganglion of the wrist, based on clinical examination or imaging findings
• age over 18 years
• ability to fill out the Finnish or English version of the questionnaires

Exclusion criteria

• pregnant or breast feeding
• other known wrist pathology that likely explains the pain
• previous surgical treatments of the wrist
• wrist ganglion presumed to be related to a work injury

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Surgery

Experimental group

Treatment:

Procedure: Arthroscopic resection

Procedure: Open resection

Conservative treatment

Active Comparator group

Treatment:

Other: Conservative treatment