NCT Number: NCT06831695
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.
Trial opening soon.
Get Notified7 year–70 year
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Up to 6 months post-surgery
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
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: Immediately post-surgery, at 3 months, and at 6 months post-surgery
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: From immediate post-surgery until hospital discharge, assessed up to 4 weeks
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.
Contact information is provided by the study sponsor or research team.
University of Health Sciences Lahore
Other
Comparison Between Surgical Outcomes of Craniotomy and Craniectomy Among Patients with Posterior Fossa Lesion
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07206849
Brain Diseases, Brain Neoplasms
View Trial DetailsNCT07739017
Astrocytoma, Brain Diseases
Herston, Queensland, Australia
View Trial DetailsNCT07732140
Aphasia, Brain Diseases
Boston, Massachusetts, United States
View Trial DetailsNCT07458113
Brain Diseases, Brain Neoplasms
New Haven, Connecticut, United States
View Trial Details