Trials / Not Yet Recruiting
Not Yet RecruitingNCT06831695
Comparison of Surgical Outcomes of Craniotomy and Craniectomy in Posterior Fossa Lesions
Comparison Between Surgical Outcomes of Craniotomy and Craniectomy Among Patients with Posterior Fossa Lesion
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- University of Health Sciences Lahore · Academic / Other
- Sex
- All
- Age
- 7 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-03-04
- Primary completion
- 2026-03-01
- Completion
- 2026-03-01
- First posted
- 2025-02-18
- Last updated
- 2025-02-18
Source: ClinicalTrials.gov record NCT06831695. Inclusion in this directory is not an endorsement.