Intra-operative Variation in Size of Brain Tumors After Craniotomy

NCT ID: NCT04365647

Last Updated: 2020-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-03-31

Brief Summary

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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

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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.

Conditions

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Brain Tumor, Primary

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patient's in whom there is increase in tumor size after craniotomy

No interventions assigned to this group

2

Patient's in whom there was either no increase in tumor size or decrease in tumor size after craniotomy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheri Kashmir Institute of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Kaushal Deep Singh

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdul R Bhat, MCh

Role: PRINCIPAL_INVESTIGATOR

Sher-i-Kashmir Institute of Medical Sciences, Soura

Locations

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Sher-i-Kashmir Institute of Medical Sciences, Soura

Srinagar, Jammu and Kashmir, India

Site Status

Countries

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India

Other Identifiers

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SKIMS, Soura

Identifier Type: -

Identifier Source: org_study_id

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