Patients and study design
Pituitary Adenomas, tumor, somatotropinoma, cerebral circulation disorder, adenoma, Somatotropinoma, acromegaly
PITUITARY ADENOMAS, GIANT, TUMOR, OTHER ENDOCRINE DISORDERS, TUMOR GROWTH, ACUTE MYOCARDIAL INFARCTION, SECONDARY, ADENOMA, SOMATOTROPINOMA, ACROMEGALY, PATHOLOGY
This study is a randomized controlled trial examining 154 patients with acromegaly. A total of 83 eligible patients underwent transspheroidal endoscopy and microscopic surgery. The interventions took place in the neurosurgical clinic of the Dr. Georgi Stranski University Hospital (Pleven, Bulgaria) within the period between 2017 and 2021. Of those operated, 50 (59.0%) were female, and 33 (41.0%) were male. The age of the study participants varied between 23 and 66 years (43.75 ± 9.23). All patients underwent primary operations. Somatotropinoma was the cause of acromegaly in all cases.The present study uses the Classification of Pituitary Adenomas developed by the Burdenko Neurosurgical Institute in Moscow, Russia. The Russian Association of Neurosurgeons recommends the mentioned Classification (Patients were randomly divided into two comparison groups depending on the applied surgical technique. The randomization process was conducted using a computer program by a specialist who was not aware of the study design. Patients were numbered from 1 to 83 by their registration sequence upon arrival for treatment. The surgical technique used was determined during the preparation of the patient for the procedure. When distributing patients into groups, their gender, age, tumor size, the direction of tumor growth, and degree of invasion were taken into account.Thus, Group 1 (n = 40) consisted of patients who underwent adenomectomy with transnasal transsphenoidal access by a microscope. Group 2 (n = 43) included patients who underwent the same surgical procedure with an endoscope. The two groups were then compared to determine which surgical method was more effective. There were no statistically significant differences between groups by sex, age, tumor size, tumor growth direction, and the invasion (P> 0.05, Mann-Whitney U-test).The inclusion criteria for the study were: 1) patients aged 18 years or older; 2) acromegaly diagnosis; 3) the evidence of microsomatotropinoma (<15 mm), small-sized somatotropinoma (16 to 25 mm) or medium somatotropinoma (26 to 35 mm); and 4) signed informed consent to participate in the study.The exclusion criteria were: 1) patients aged under 18 years; 2) patients with large or giant somatotropinoma (>35 mm); 3) laterosellar expansion of the adenoma with secondary non-capsular nodes, a small sella turcica, or a narrow entrance to the secondary nodes of the tumor; 4) refusal to undergo surgical intervention for acromegaly; 4) patients diagnosed with other endocrine disorders that may affect the outcome; 5) acute myocardial infarction earlier than 3 months prior to the study; 6) acute cerebral circulation disorder earlier than 3 months prior to the study; 7) decompensated concomitant pathology; 8) mental illness; 9) refusal to participate in the study.Patients were observed postoperatively during hospital stay and within one month after their discharge. All data obtained during the study were kept in a database and processed after all patients underwent the necessary procedures. Study design.