Clinical trial · Interventional
Comparison of Surgical Outcomes of Craniotomy and Craniectomy in Posterior Fossa Lesions
Comparison Between Surgical Outcomes of Craniotomy and Craniectomy Among Patients with Posterior Fossa Lesion
NCT06831695CI-TRIAL-00086141not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Posterior Fossa Lesion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Craniectomy | Procedure | — | UNRESOLVED |
| Craniotomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A: Craniotomy
- description
- 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.
- interventionNames
- Procedure: Craniotomy
- type
- ACTIVE_COMPARATOR
- label
- Group B: Craniectomy
- description
- 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.
- interventionNames
- Procedure: Craniectomy
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 7 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with posterior fossa lesions * Age range: 7-70 years * Patients with cerebellar hematoma (traumatic or spontaneous) Exclusion Criteria: * Previous posterior fossa surgery * Brainstem hematoma * Tumors involving the overlying dura or bone
References
Publications (0)
Data not yet available
No reference posted for this study.