Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
Study NCT ID:
NCT06831695
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-18
First Post:
2025-02-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of Surgical Outcomes of Craniotomy and Craniectomy in Posterior Fossa Lesions
Sponsor:
University of Health Sciences Lahore
Organization:
Study Overview
Official Title:
Comparison Between Surgical Outcomes of Craniotomy and Craniectomy Among Patients with Posterior Fossa Lesion
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: