跳至主要内容
临床试验/NCT04365647
NCT04365647已完成不适用

Intra-operative Variation in Size of Brain Tumors After Craniotomy - Observational Comparative Imaging Study

Sheri Kashmir Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
51
试验地点
1
主要终点
Tumor dimension change

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Tumor dimension change

时间窗: March 2018 to November 2019

Change in tumor dimension, surface area and volume when comparing intraoperative ultrasound with pre-operative CEMRI and CECT brain

次要结局

  • Tumor distance from dural surface(March 2018 to November 2019)
  • Relationship of tumor size change with other characteristics(March 2018 to November 2019)

研究者

发起方
Sheri Kashmir Institute of Medical Sciences
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kaushal Deep Singh

Doctor

Sheri Kashmir Institute of Medical Sciences

研究点 (1)

Loading locations...

相似试验