Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:47 PM
Study NCT ID:
NCT03471494
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2018-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GlobalSurg 3: Quality and Outcomes in Global Cancer Surgery
Sponsor:
University of Edinburgh
Organization:
Study Overview
Official Title:
GlobalSurg 3: Quality and Outcomes in Global Cancer Surgery
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GS3
Brief Summary:
Aim The aim is to determine the variation in quality of cancer surgery worldwide. Quality will be determined using measures covering infrastructure, care processes, and outcomes. The study will concentrate on the most common surgically treated cancers worldwide: breast, gastric and colorectal cancer. The primary aim focusses on 30-day mortality and complication rates after cancer surgery. The secondary aim is to characterise infrastructure and care processes in the treatment of these cancers worldwide.
Primary outcome measure 30-day mortality and complication rates after cancer surgery.
Primary comparison Between country groups defined by human development index.
Hospital eligibility Any hospital in the world performing surgery for breast, gastric or colorectal cancer.
Patient eligibility Consecutive patients undergoing surgery for breast, gastric, or colorectal cancer. Surgery can be with palliative or curative intent.
Team Individual hospital teams with up to three people, collecting data for four weeks. Several teams collecting data over multiple four-week periods is encouraged.
Time period Patients will be identified, and data collected on all patients during the time-period with follow-up to 30-days. The study will run from 1st April 2018 to 31st October 2018 (with follow-up of the last period to 30th November 2018).
Validation Data validation will be in two parts. First, centres will self-report the key processes used to identify and follow-up patients. Second, independent validators will quantitatively report case ascertainment and sampled data accuracy.
Primary outcome measure 30-day mortality and complication rates after cancer surgery.
Primary comparison Between country groups defined by human development index.
Hospital eligibility Any hospital in the world performing surgery for breast, gastric or colorectal cancer.
Patient eligibility Consecutive patients undergoing surgery for breast, gastric, or colorectal cancer. Surgery can be with palliative or curative intent.
Team Individual hospital teams with up to three people, collecting data for four weeks. Several teams collecting data over multiple four-week periods is encouraged.
Time period Patients will be identified, and data collected on all patients during the time-period with follow-up to 30-days. The study will run from 1st April 2018 to 31st October 2018 (with follow-up of the last period to 30th November 2018).
Validation Data validation will be in two parts. First, centres will self-report the key processes used to identify and follow-up patients. Second, independent validators will quantitatively report case ascertainment and sampled data accuracy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: