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

Completed

• Conditions: Craniectomy; Quality of Life; Cerebellar Haematoma; Handicaps Physical; Handicap Mental
• Interventions: Behavioral: SF36 questionary

• Registration Number: NCT04672785
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study First Submitted: 2020-12-11
• Study First Submitted QC: 2020-12-16
• Study Start: 2020-12-17
• Study First Posted: 2020-12-17
• Primary Completion: 2021-02-26
• Status Verified: 2021-04
• Study Completion: 2021-05-12
• Last Update Submitted: 2021-05-27
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who underwent a posterior fossa craniectomy for a cerebellar hematoma	SF36 questionary	-

Primary Outcome Measures

Name	Time	Method
Evaluate the level of handicap	through study completion, an average of 1 years post admission	The mRS (Modified Ranking score) measured at least one year following the ICU discharge during the consultation after hospitalization in the medical file

Secondary Outcome Measures

Name	Time	Method
Global quality of life score	from january 2020, during 6 months	the SF36 score assessing the quality of life, collected via phone call.
Neurological recovery	from january 2020, during 6 months	the GOS (Glasgow Outcome Scale) score measured at least one year following the discharge from intensive care. It goes from 1 to 5.; 1 corresponds to death 5.Good Recovery

Trial Locations

Locations (1)

CHUGA; 🇫🇷 Grenoble, France