Ganglion Resection Effectiveness Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Open resection, Arthroscopic resection, Conservative treatment.
- Who it may be relevant to
- Registry conditions: Wrist Ganglion, Ganglion, Ganglion Cyst, Connective Tissue Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland, Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
GangLion Resection Effectiveness Trial (GangLion): a Multicentre, Randomized, Superiority Trial
Overview
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.
Interventions
- 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
Primary outcome measures
- Patient-Rated Wrist/Hand Evaluation (PRWHE) pain score [Time frame: 6 months follow-ups]
Secondary outcome measures (9)
- PRWHE pain score [Time frame: 3 and 12 months follow-ups]
- PRWHE function score [Time frame: 3, 6, and 12 months follow-ups]
- PRWHE total score [Time frame: 3, 6, and 12 months follow-ups]
- Global improvement [Time frame: 3, 6, and 12 months follow-ups]
- Patient Accepted Symptom State (PASS) [Time frame: 3, 6, and 12 months follow-ups]
- Health-related quality of life [Time frame: 3, 6, and 12 months follow-ups]
- Presence of the ganglion [Time frame: 6 months follow-ups]
- Duration of sick leave [Time frame: 6 months follow-ups]
- Adverse events [Time frame: 3, 6, and 12 months follow-ups]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Finland · 3 centers
- Helsinki University Hospital — Helsinki
- Hospital Nova of Central Finland — Jyväskylä
- Tampere University Hospital — Tampere
Singapore · 1 center
- National University Hospital — Singapore
Identifiers
NCT: NCT07162415 · R25038