NCT Number: NCT07162415
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Helsinki University Hospital, Helsinki, Finland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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."
Time frame: 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'.
Time frame: 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").
Time frame: 6 months follow-ups
The presence of the ganglion will be assessed through clinical examination.
Time frame: 6 months follow-ups
The duration of sick leave is measured in days.
Time frame: 3, 6, and 12 months follow-ups
Contact information is provided by the study sponsor or research team.
Tampere University Hospital
Other
GangLion Resection Effectiveness Trial (GangLion): a Multicentre, Randomized, Superiority Trial
Acronym: GangLion
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07477197
Adult Congenital Heart Disease, Cardiovascular Abnormalities
Cincinnati, Ohio, United States
View Trial DetailsNCT06917690
Collagen Diseases, Congenital Abnormalities
Fukuoka, Japan
View Trial DetailsNCT06696027
ANCA Associated Vasculitis (AAV), Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Bonn, North Rhine-Westphalia, Germany
View Trial DetailsNCT06779799
Cardiovascular Diseases, Connective Tissue Disease
Brest, France
View Trial Details