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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 7 to 70 years
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Comparison Between Surgical Outcomes of Craniotomy and Craniectomy Among Patients with Posterior Fossa Lesion

Conditions

Posterior Fossa Lesion

Being tested

Craniotomy, Craniectomy

Keywords

Craniotomy, Craniectomy, Neurosurgery, Posterior Fossa, Brain Tumors

Medical subject headings

Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• CraniotomyProcedure or surgery

  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.

• CraniectomyProcedure or surgery

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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.

   Measured: Up to 6 months post-surgery

2. 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.

   Measured: Up to 6 months post-surgery

3. 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.

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

4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted18 Feb 2025
2. Study start4 Mar 2025 (estimated)
3. Primary completionMar 2026 (estimated)
4. Study completionMar 2026 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Posterior Fossa LesionStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.