Ganglion Resection Effectiveness Trial

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07162415
• Lead Sponsor: Tampere University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-01
• Study First Submitted QC: 2025-09-01
• Last Update Submitted: 2025-09-01
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09
• Study Start: 2025-11-01
• Primary Completion: 2034-12
• Study Completion: 2035-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient-Rated Wrist/Hand Evaluation (PRWHE) pain score	6 months follow-ups	The PRWHE is a 15-item questionnaire that is designed to measure wrist pain and disability in activities of daily living. Symptoms are described as average over the past week. The PRWHE consists of two subscales: pain and function. The PRWHE pain includes five items with combined score from 0 (no pain) to 50 (worst ever).

Secondary Outcome Measures

Name	Time	Method
PRWHE pain score	3 and 12 months follow-ups	The PRWHE is a 15-item questionnaire that is designed to measure wrist pain and disability in activities of daily living. Symptoms are described as average over the past week. The PRWHE consists of two subscales: pain and function. The PRWHE pain includes five items with combined score from 0 (no pain) to 50 (worst ever).
PRWHE function score	3, 6, and 12 months follow-ups	The PRWHE is a 15-item questionnaire that is designed to measure wrist pain and disability in activities of daily living. Symptoms are described as average over the past week. The PRWHE consists of two subscales: pain and function. Score of the PRWHE function ranges from 0 (no difficulty) to 50 (unable to do).
PRWHE total score	3, 6, and 12 months follow-ups	The PRWHE is a 15-item questionnaire that is designed to measure wrist pain and disability in activities of daily living. Symptoms are described as average over the past week. The PRWHE consists of two subscales: pain and function. The PRWHE total ranges from 0 (best) to 100 (worst).
Global improvement	3, 6, and 12 months follow-ups	Self-reported global improvement will be gathered as 7-step Likert scale as a response to question: "Compared with the beginning of the study, my wrist feels much worse - somewhat worse - little worse - no change - little better - somewhat better - much better."
Patient Accepted Symptom State (PASS)	3, 6, and 12 months follow-ups	PASS will be assessed using the question: "Considering the current symptoms and function of your wrist, are you satisfied with the outcome?" Participants will respond with either 'yes' or 'no'.
Health-related quality of life	3, 6, and 12 months follow-ups	Health-related quality of life is measured by EuroQol visual analogue scale (EQ VAS). EQ VAS is a component of 5-level EQ-5D questionnaire. It measures patient's overall current health-related quality of life in a 20 cm visual analogue scale. The scale ranges from 100 ("the best health state you can imagine") to 0 ("the worst health you can imagine").
Presence of the ganglion	6 months follow-ups	The presence of the ganglion will be assessed through clinical examination.
Duration of sick leave	6 months follow-ups	The duration of sick leave is measured in days.
Adverse events	3, 6, and 12 months follow-ups

Trial Locations

Locations (4)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Hospital Nova of Central Finland; 🇫🇮 Jyväskylä, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

National University Hospital; 🇸🇬 Singapore, Singapore