Clinical Research Directory
Browse clinical research sites, groups, and studies.
Comparison of Extent of Resection of Pituitary Adenoma Via Transnasal Transsphenoidal Approach Using Endoscope Versus Microscope
Sponsor: Sir Ganga Ram Hospital
Summary
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.
Key Details
Gender
All
Age Range
20 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2022-12-04
Completion Date
2023-12-03
Last Updated
2026-10-21
Healthy Volunteers
No
Conditions
Interventions
Endoscopic surgery
Endoscopic transnasal transsphenoidal surgery was performed for pituitary adenoma resection. The procedure involved sphenoidotomy, exposure of the sellar floor, creation of a sellar bony window, opening of the dura, and tumor removal by circumferential extracapsular debulking and piecemeal internal decompression. An angled endoscope was used when required to visualize the cavernous sinus. Tumor severely adherent to the internal carotid artery or pituitary gland was not removed. The sellar floor was repaired using an abdominal fat graft or fascia lata. Postoperative MRI was performed six weeks after surgery.
Microscopic surgery
Microscopic transnasal transsphenoidal surgery was performed for pituitary adenoma resection. The procedure involved a right nostril mucosal incision, creation of a submucosal plane along the nasal septum, insertion of a Killian speculum, and exposure of the sphenoid sinus using an operating microscope. The sphenoid opening was enlarged, and the sellar position was confirmed using image guidance. The dura was incised, and the tumor was identified and excised. The sellar floor was packed, and the speculum was removed. The septum was returned to the midline, and the nasal mucosa was repositioned. Postoperative MRI was performed six weeks after surgery.
Locations (1)
Department of Neurosurgery
Lahore, Punjab Province, Pakistan