We are very pleased to announce the latest publication of the DIST pilot study group in Acta Neurochirugica (Wien):
Safety and technical efficacy of early minimally invasive endoscopy-guided surgery for intracerebral haemorrhage: the Dutch Intracerebral haemorrhage Surgery Trial pilot study | SpringerLink
In preparation of the Dutch ICH Surgery Trial, that already randomized its first patients, we engaged in ensuring the safety and technical efficacy of minimally invasive endoscopy guided surgery for intracerebral hemorrhage within 8 hours after symptom onset.
We need to progress our work within the DIST to determine whether this intervention also improves functional outcome of patients with this detrimental disease with its current high mortality and morbidity.
On March 17th, the first amendment of the study protocol was accepted by the MEC. The most important changes are the addition of the EQ-5D-5L assessment on day 6 and the separate information letters 'patient in 2e instantie’ and ‘na overlijden’. The most current versions of all updated documents, can be found on the website under ‘’Trial protocol and documents’.
Read our fourth DIST newsletter of March 2022 (#4) here.
The DIST has had a positive start to 2023, with the DIST going live in Amsterdam and the inclusion of new participants in the Erasmus MC. Furthermore, MST, Isala and MUMC+ are almost ready to start the run-in phase of the DIST. Find out more in the DIST newsletter of January 2023 (#3) here.
Amsterdam UMC is now officially live and ready for inclusion.
On November 29th, the first patient was included in the Radboudumc! In addition, Erasmus MC has included two more patients in the past month, bringing the counter to 4 inclusions! Read our second DIST newsletter of December 2022 (#2) here.
On November 3rd, the first patient was included in the DIST in the Erasmus MC! With this first inclusion, the DIST has officially started.
Read our first DIST newsletter of November 2022 (#1) here.
The Dutch ICH Surgery Trial is officially LIVE! The Radboudumc and Erasmus MC are initiated and ready for inclusion.
The Medical Ethical Committee has given approval to start the trial!
On April 5, 6 and 7, the neurosurgeons were trained in the minimmaly invasive endoscopy-assisted procedure and the use of the Artemis neuro-evacuation device.
The DIST has been awarded the Veelbelovende Zorg (Promising Care) grant from the Zorginstituut Nederland and ZonMw. The awarded grant of 5 million euros enables us to extend the follow-up of all participants from 6 to 12 months, perform a cost-effectiveness and budget impact analysis, and to reimburse the costs of the procedure during the trial. See also: https://www.radboudumc.nl/nieuws/2022/groot-onderzoek-naar-effect-nieuw-soort-operatie-na-hersenbloeding.
The DIST has been submitted to the medical ethics committee for approval.