Clinical trial NCT04672785: Long-term Outcomes in Terms of Disability and Quality of Life for Patients Undergoing Posterior Cranial Fossa Craniectomy in the Context of Compressive Cerebellar Hematoma
Official title: Long-term Outcomes in Terms of Disability and Quality of Life for Patients Undergoing Posterior Cranial Fossa Craniectomy in the Context of Compressive Cerebellar Hematoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniectomy
Quality of Life
Cerebellar Haematoma
Handicaps Physical
Handicap Mental
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every patients who underwent a posterior fossa craniectomy for a cerebellar hematoma at Grenoble University Hospital between 01/01/2010 and 01/01/2020

Brief summary: Posterior cranial fossa craniectomy has been shown to improve patient survival. The level of autonomy, disability and quality of life of survivors has been little studied and still underresearched,.

In this context, an assessment of the level of disability and of the quality of life after performing a posterior craniectomy seems relevant.

Detailed description: Investigators are carrying out a retrospective observational, single-center study, in three intensive care units in the Grenoble Hospital Center. Every patients who underwent a posterior fossa craniectomy for a cerebellar hematoma at Grenoble University Hospital between 01/01/2010 and 01/01/2020 were enrolled in this study. The main objective is to assess the level of disability and the quality of life of patients who have had a posterior cranial fossa craniectomy. The primary outcome is the mRS(Modified Rankin score) measured at least one year following the ICU discharge. Secondary outcomes are the mRS(Modified Rankin Score) measured at discharge from the rehabilitation department, the GOS (Glasgow Outcome score) measured at least one year following the discharge from intensive care, and the SF36 (The Short Form 36)from the medical outcome study, score assessing the quality of life, collected via phone call.

Eligibility criteria: Inclusion Criteria:

* Patient who underwent a posterior cranial fossa craniectomy in the context of an acute cerebellar hematoma between January 01, 2012 to January 01, 2020.
* Adult man or woman
* Hospitalized in intensive care
* No opposition from the patient or a loved one to a telephone contact to determine the SF36 (The Short Form) quality of life scale, from the medical outcome study.

Exclusion Criteria:

* Subject under guardianship or subject deprived of liberty
* Early limitation of active therapy before 48 hours.

Primary outcomes:
measure: Evaluate the level of handicap
timeFrame: through study completion, an average of 1 years post admission
Secondary outcomes:
measure: Global quality of life score
timeFrame: from january 2020, during 6 months
measure: Neurological recovery
timeFrame: from january 2020, during 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHUGA
Study officials:
References: