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

NCT06831695 | Not Yet Recruiting

• 1 other identifier: Exp128
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Posterior Fossa Lesion

Keywords

Craniotomy; Craniectomy; Neurosurgery; Posterior Fossa; Brain Tumors

Outcome Measures

Primary Outcomes (4)

• Incidence of CSF leakage

  Definition: CSF leakage is defined as the presence of clear fluid discharge from the surgical site, confirmed via clinical examination and biochemical analysis of β-2 transferrin. Measurement: Evaluated by clinical assessment at routine follow-ups and imaging studies when indicated.

  Up to 6 months post-surgery

• Occurrence of pseudomeningocele

  Definition: Pseudomeningocele is defined as an abnormal collection of cerebrospinal fluid in the surgical site, detected through physical examination and confirmed by imaging techniques such as MRI or CT scan. Measurement: Follow-up visits at 1, 3, and 6 months post-surgery.

  Up to 6 months post-surgery

• Severity of post-operative headache

  Definition: Post-operative headache will be assessed using the Catalano grading system, categorizing severity from 0 (no headache) to 4 (severe, refractory to medication). Measurement: Self-reported patient evaluations at each follow-up visit.

  Immediately post-surgery, at 3 months, and at 6 months post-surgery

• Length of hospital stay

  Definition: The total number of days a patient remains hospitalized post-surgery, including any extended stay due to complications. Measurement: Recorded from hospital admission to discharge.

  From immediate post-surgery until hospital discharge, assessed up to 4 weeks

Study Arms (2)

Group A: Craniotomy

ACTIVE COMPARATOR

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: Craniotomy

Group B: Craniectomy

ACTIVE COMPARATOR

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.

Procedure: Craniectomy

Interventions

Craniotomy PROCEDURE

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.

Group A: Craniotomy

Craniectomy PROCEDURE

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.

Group B: Craniectomy

Eligibility Criteria

• Age: 7 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with posterior fossa lesions
• Age range: 7-70 years
• Patients with cerebellar hematoma (traumatic or spontaneous)

You may not qualify if:

• Previous posterior fossa surgery
• Brainstem hematoma
• Tumors involving the overlying dura or bone

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Craniotomy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Dr. Birat Thapa Magar, Post Graduate Resident

CONTACT

+923057895437; biratjmagar.5@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 18, 2025
• Study Start: March 4, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02