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

NCT04672785 | Completed

• 2 other identifiers: 38RC20.3552020-A02717-32
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Craniectomy; Quality of Life; Cerebellar Haematoma; Handicaps Physical; Handicap Mental

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Global quality of life score

  from january 2020, during 6 months

• Neurological recovery

  from january 2020, during 6 months

Study Arms (1)

Patients who underwent a posterior fossa craniectomy for a cerebellar hematoma

Behavioral: SF36 questionary

Interventions

SF36 questionary BEHAVIORAL

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.

Patients who underwent a posterior fossa craniectomy for a cerebellar hematoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

CHUGA

Grenoble, 38043, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: December 17, 2020
• Study Start: December 17, 2020
• Primary Completion: February 26, 2021
• Study Completion: May 12, 2021
• Last Updated: May 28, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)