GangLion Resection Effectiveness Trial (GangLion): a Multicentre, Randomized, Superiority Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Tampere University Hospital
- Enrollment
- 220
- Locations
- 6
- Primary Endpoint
- Patient-Rated Wrist/Hand Evaluation (PRWHE) pain score
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Due to the nature of the interventions and inability to blind the participants with placebo surgery (as the visible mass would reveal the allocation after surgery), blinding is not possible. Since the outcomes are participant reported, we will not attempt to blind the investigator or other personnel.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Patient-Rated Wrist/Hand Evaluation (PRWHE) pain score
Time Frame: 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 Outcomes
- PRWHE pain score(3 and 12 months follow-ups)
- PRWHE function score(3, 6, and 12 months follow-ups)
- PRWHE total score(3, 6, and 12 months follow-ups)
- Global improvement(3, 6, and 12 months follow-ups)
- Patient Accepted Symptom State (PASS)(3, 6, and 12 months follow-ups)
- Presence of the ganglion(6 months follow-ups)
- Health-related quality of life(3, 6, and 12 months follow-ups)
- Duration of sick leave(6 months follow-ups)
- Adverse events(3, 6, and 12 months follow-ups)