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

NCT06831695 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-02-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Health Sciences Lahore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-04
Primary Completion
2026-03-31
Completion
2026-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06831695 on ClinicalTrials.gov