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

Quality of Life Clinical Trial

— CHANCE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04672785
• Other study ID #: 38RC20.355
• Secondary ID: 2020-A02717-32
• Status: Completed
• Start date: December 17, 2020
• Est. completion date: May 12, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 12, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebellar Haematoma
• Craniectomy
• Handicap Mental
• Handicaps Physical
• Hematoma
• Quality of Life

Intervention

Behavioral:
• SF36 questionary
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.

Locations

Country	Name	City	State
France	CHUGA	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the level of handicap	The mRS (Modified Ranking score) measured at least one year following the ICU discharge during the consultation after hospitalization in the medical file	through study completion, an average of 1 years post admission
Secondary	Global quality of life score	the SF36 score assessing the quality of life, collected via phone call.	from january 2020, during 6 months
Secondary	Neurological recovery	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	from january 2020, during 6 months