Randomized clinical trial to compare the results of pituitary macroadenoma surgery in intraoperative guidance vs conventional fluoroscopic guidance.
Not Applicable
- Conditions
- Health Condition 1: null- A patient of pituitary macroadenoma usually suffers with endocrinological problems or with problems associated with mass effect of tumor on adjacent structures.
- Registration Number
- CTRI/2013/07/003798
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
1.Pituitary macroadenoma
2.Size - From 1 cm to 4 cm
3.Proper consent available and willing for regular follow up till 3 months
Exclusion Criteria
1.Age greater than or equal to 18 years
2.Microadenoma
3.Tumor size more than 4 cm in any dimension.
4.Involving two compartments or more.
5.Tumor reaching within 6mm of foramen of monro
6.Absolute Contraindication for trans-sphenoidal surgery â?? Acute Sphenoid sinusitis
7.Re-do surgery
8.Adjuvant Radiotherapy/ Gamma knife radiosurgery
9.Radiological or intra-operative evidence of extensive bone, duramater and sinuses involvement
10.Radiological evidence of > 50% encasement of ICA circumference
11.Histopathology report other than those categorised as pituitary adenomas
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of tumor removed.Timepoint: Immediate post operative period
- Secondary Outcome Measures
Name Time Method 1. Residual /recurrent tumor <br/ ><br>2. Assess and compare short term outcome in the two armsTimepoint: Three months.