Comparison of Extent of Resection of Pituitary Adenoma Via Transnasal Transsphenoidal Approach Using Endoscope Versus Microscope

Study acronym: GTR MRI
StatusCompleted
PhaseNot applicable
Started

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Record History

  1. Study First Submitted
This randomized controlled trial, titled "Comparison of Extent of Resection of Pituitary Adenoma via Transnasal Transsphenoidal Approach Using Endoscope Versus Microscope," was conducted in the Department of Neurosurgery, Sir Ganga Ram Hospital, Lahore, Pakistan, from 04 December 2022 to 03 December 2023. The objective was to compare the extent of pituitary adenoma resection using endoscopic and microscopic transnasal transsphenoidal surgery. A total of 38 patients aged 20-60 years of either gender were included. Patients with recurrent pituitary tumors or tumors with suprasellar or parasellar extension were excluded. Eligible patients were randomly allocated in a 1:1 ratio using random allocation software, and allocation concealment was maintained through sequentially numbered, sealed, opaque envelopes. Group A underwent endoscopic surgery, while Group B underwent microscopic surgery. Preoperative assessment included magnetic resonance imaging (MRI), hormonal investigations, perimetry, and routine investigations required for general anesthesia. Tumor volume was calculated using the specified geometrical formula based on tumor dimensions. Both surgical procedures were performed by the same surgical team to maintain consistency. Postoperative MRI was performed six weeks after surgery to assess residual tumor volume and extent of resection. Gross total resection (GTR) was defined as residual tumor volume below 10%, while subtotal resection was defined as residual tumor volume above 10%. The primary outcome was the extent of tumor resection assessed on postoperative MRI. Secondary outcomes included the percentage of tumor resected, tumor volume extracted, and duration of surgery. Data were analyzed using SPSS version 25.0. Quantitative variables were compared using the independent-samples t-test, while categorical variables were compared using the chi-square or Fisher's exact test, as appropriate. A p-value ≤0.05 was considered statistically significant. Ethical approval was obtained from the institutional ethics committee, and written informed consent was obtained from all participants.
Trial Details
NCT Number NCT07886242
Lead Sponsor Sir Ganga Ram Hospital
Conditions
(from sponsor)
Pituitary Adenoma
Related terms Pituitary Neoplasms
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov