Intra-operative Variation in Size of Brain Tumors After Craniotomy

Completed

• Conditions: Brain Tumor, Primary

• Registration Number: NCT04365647
• Lead Sponsor: Sheri Kashmir Institute of Medical Sciences

Brief Summary

We planned to evaluate the change in tumor dimensions of intraaxial parenchymal tumors after craniotomy by comparing the tumor size on intraoperative ultrasonography (IOUSG) with pre-operative CECT and CEMRI brain.

Detailed Description

Background: No previous study to determine the intraoperative changes in the tumor dimensions had been undertaken previously. Objectives: We planned to evaluate the change in tumor dimensions of intraaxial parenchymal tumors after craniotomy by comparing the tumor size on intraoperative ultrasonography (IOUSG) with pre-operative CECT and CEMRI brain. Study Design: This was a prospective observational study. Participants: Patients aged 15-65 years undergoing surgery at SKIMS for intraaxial parenchymal intracranial tumors were included. Methods: Standard pre-operative CECT and CEMRI brain were done to measure tumor dimensions and compared with IOUSG.

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2019-11-01
• Study Completion: 2020-03-31
• Status Verified: 2020-04
• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-24
• Last Update Submitted: 2020-04-24
• Study First Posted: 2020-04-28
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• All patients above the age of 15 years conferring to Grade I and II of American Society of Anesthesiologist (ASA) physical status classification system, undergoing elective craniotomy with intracranial tumor excision were included in this study. Patients with or without any neuro-deficit were also included. Only those patients in whom all the tumor dimensions could be defined with precision on pre-operative CECT, CEMRI and IOUSG were included in the final analysis.

Exclusion Criteria

• Patients' in whom there are multiple intracranial tumors (e.g. metastasis), deep seated tumors, inability to use IOUSG and in whom exact tumor dimensions cannot be defined either on pre-operative CECT/CEMRI or on IOUSG were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tumor dimension change	March 2018 to November 2019	Change in tumor dimension, surface area and volume when comparing intraoperative ultrasound with pre-operative CEMRI and CECT brain

Secondary Outcome Measures

Name	Time	Method
Tumor distance from dural surface	March 2018 to November 2019	Change in the distance of tumor from dural surface as measured on intraoperative ultrasound when comparing it with pre-operative CEMRI and CECT brain
Relationship of tumor size change with other characteristics	March 2018 to November 2019	Relationship of tumor size change with tumor consistency, tumor characteristics, histopathology, tumor location

Trial Locations

Locations (1)

Sher-i-Kashmir Institute of Medical Sciences, Soura; 🇮🇳 Srinagar, Jammu And Kashmir, India