Clinical Trials Directory

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

TypeNameDescription
PROCEDURECraniotomyIntervention: 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.
PROCEDURECraniectomyIntervention: 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.