Comparison of Surgical Outcomes of Craniotomy and Craniectomy in Posterior Fossa Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Craniotomy, Craniectomy.
- Who it may be relevant to
- Registry conditions: Posterior Fossa Lesion. Basic parameters: 7 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison Between Surgical Outcomes of Craniotomy and Craniectomy Among Patients with Posterior Fossa Lesion
Overview
The purpose of this randomized controlled trial is to compare the surgical outcomes of craniotomy and craniectomy among patients with posterior fossa lesions. The study aims to determine differences in post-operative complications, hospital stay duration, and patient recovery between the two surgical techniques.
Detailed description
Patients diagnosed with posterior fossa lesions will be randomly assigned into two groups. Group A will undergo craniotomy, where the bone flap is replaced after dural closure, while Group B will undergo craniectomy, where the bone is permanently removed. Outcomes will be assessed based on post-operative complications such as CSF leakage, pseudomeningocele formation, post-operative headache, and length of hospital stay. The study aims to provide evidence to determine the superior surgical approach in terms of patient outcomes and healthcare cost reduction.
Interventions
- Procedure Craniotomy
Intervention: Bone flap replaced after dural closure Additional Information: This procedure involves creating a single free bone flap using high-speed drills. The bone is repositioned and secured using mini plates or sutures after the surgical intervention is completed. Post-operative monitoring will include assessment for CSF leakage, wound healing, and neurological recovery. - Procedure Craniectomy
Intervention: Bone permanently removed Additional Information: In this approach, the bone is removed in pieces using rongeurs, leaving an open dural surface without replacement of the bone. The dura is closed with sutures, and dural augmentation may be performed as needed. Post-operative assessment will focus on complications such as pseudomeningocele, CSF leakage, and extended hospital stays.
Primary outcome measures
- Incidence of CSF leakage [Time frame: Up to 6 months post-surgery]
- Occurrence of pseudomeningocele [Time frame: Up to 6 months post-surgery]
- Severity of post-operative headache [Time frame: Immediately post-surgery, at 3 months, and at 6 months post-surgery]
- Length of hospital stay [Time frame: From immediate post-surgery until hospital discharge, assessed up to 4 weeks]
Eligibility criteria
Inclusion criteria
- Patients diagnosed with posterior fossa lesions
- Age range: 7-70 years
- Patients with cerebellar hematoma (traumatic or spontaneous)
Exclusion criteria
- Previous posterior fossa surgery
- Brainstem hematoma
- Tumors involving the overlying dura or bone
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06831695 · Exp128