Intra-operative Variation in Size of Brain Tumors After Craniotomy

April 24, 2020 updated by: Kaushal Deep Singh, Sheri Kashmir Institute of Medical Sciences

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Jammu And Kashmir
      • Srinagar, Jammu And Kashmir, India, 190011
        • Sher-i-Kashmir Institute of Medical Sciences, Soura

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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 intracranial tumor surgery at our institute in the specified period.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
1
Patient's in whom there is increase in tumor size after craniotomy
2
Patient's in whom there was either no increase in tumor size or decrease in tumor size after craniotomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Tumor dimension change
Time Frame: March 2018 to November 2019
Change in tumor dimension, surface area and volume when comparing intraoperative ultrasound with pre-operative CEMRI and CECT brain
March 2018 to November 2019

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tumor distance from dural surface
Time Frame: 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
March 2018 to November 2019
Relationship of tumor size change with other characteristics
Time Frame: March 2018 to November 2019
Relationship of tumor size change with tumor consistency, tumor characteristics, histopathology, tumor location
March 2018 to November 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sheri Kashmir Institute of Medical Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Abdul R Bhat, MCh, Sher-i-Kashmir Institute of Medical Sciences, Soura

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SKIMS, Soura

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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