An interventional study of Craniotomy and Craniectomy in Posterior Fossa Lesion, sponsored by University of Health Sciences Lahore. Not yet recruiting. Open to participants aged 7 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-18.
Sponsored by University of Health Sciences Lahore · Not applicable, Interventional, and Treatment
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.
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.
University of Health Sciences Lahore is the lead sponsor of 77 studies on the registry; 49 are open to participants now.
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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
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
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From immediate post-surgery until hospital discharge, assessed up to 4 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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University of Health Sciences Lahore