Trials / Recruiting
RecruitingNCT07162415
Ganglion Resection Effectiveness Trial
GangLion Resection Effectiveness Trial (GangLion): a Multicentre, Randomized, Superiority Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 220 (estimated)
- Sponsor
- Tampere University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Open resection | A transverse or longitudinal incision is done depending on surgeon's preference. The ganglion and its pedicle are traced up to its origin. The pedicle is resected tangentially, usually, from the SL ligament for dorsal ganglions and depending on the site for volar ganglion. Wrist capsule is not closed. |
| PROCEDURE | Arthroscopic resection | Portals are selected by surgeon's preference. The pedicle of the ganglion is located and resected with a shaver. It is not necessary to remove all the ganglion walls. The portal incisions do not need to be sutured. |
| OTHER | Conservative treatment | Participant will be informed about the natural course of wrist ganglions. The conservative treatment may include needle aspiration of the ganglion, but it is not performed routinely. Participants are informed that wrist loading in extension may exacerbate the pain, and that the pain is not a sign of further injury to wrist joint. They can avoid heavy use it if they have too much pain, but they are advised to use hand as tolerated. Participants may use NSAIDs and acetaminophen for pain management as needed; however, the protocol does not specify a required course or dosage. A simple self-implemented exercise therapy instructions are given to every participant. |
Timeline
- Start date
- 2026-01-13
- Primary completion
- 2034-12-01
- Completion
- 2035-12-01
- First posted
- 2025-09-09
- Last updated
- 2026-01-21
Locations
4 sites across 2 countries: Finland, Singapore
Source: ClinicalTrials.gov record NCT07162415. Inclusion in this directory is not an endorsement.