Ganglion Resection Effectiveness Trial

Официальное название

GangLion Resection Effectiveness Trial (GangLion): a Multicentre, Randomized, Superiority Trial

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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.
• Другое 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

Первичные конечные точки

• Patient-Rated Wrist/Hand Evaluation (PRWHE) pain score [Срок оценки: 6 months follow-ups]

Вторичные конечные точки (9)

• PRWHE pain score [Срок оценки: 3 and 12 months follow-ups]
• PRWHE function score [Срок оценки: 3, 6, and 12 months follow-ups]
• PRWHE total score [Срок оценки: 3, 6, and 12 months follow-ups]
• Global improvement [Срок оценки: 3, 6, and 12 months follow-ups]
• Patient Accepted Symptom State (PASS) [Срок оценки: 3, 6, and 12 months follow-ups]
• Health-related quality of life [Срок оценки: 3, 6, and 12 months follow-ups]
• Presence of the ganglion [Срок оценки: 6 months follow-ups]
• Duration of sick leave [Срок оценки: 6 months follow-ups]
• Adverse events [Срок оценки: 3, 6, and 12 months follow-ups]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Финляндия · 3 центра

• Helsinki University Hospital — Helsinki
• Hospital Nova of Central Finland — Jyväskylä
• Tampere University Hospital — Tampere

Сингапур · 1 центр

• National University Hospital — Singapore

Идентификаторы

NCT: NCT07162415 · R25038

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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