Comparison of Surgical Outcomes of Craniotomy and Craniectomy in Posterior Fossa Lesions

University of Health Sciences Lahore

Status: Not yet enrolling

Conditions: Posterior Fossa Lesion

Treatments: Procedure: Craniotomy; Procedure: Craniectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06831695

Exp128

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 7 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Group A: Craniotomy

Active Comparator group

Description:

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.

Treatment:

Procedure: Craniotomy

Group B: Craniectomy

Active Comparator group

Description:

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.

Treatment:

Procedure: Craniectomy