GlobalSurg 3: Quality and Outcomes in Global Cancer Surgery (GS3)

June 6, 2024 updated by: University of Edinburgh

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15958

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

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective or emergency surgery for breast, gastric, or colorectal cancer anywhere in the world are eligible.

Description

Inclusion Criteria:

  • All consecutive patients undergoing therapeutic surgery (curative or palliative) for breast, gastric, and colorectal cancer should be included.
  • Surgery is defined as a procedure requiring a skin incision performed under general or neuraxial (e.g. regional, epidural or spinal) anaesthesia.
  • Both elective and emergency procedures should be included. Include patients in whom the pre-operative diagnosis was thought to be benign, but was subsequently found to be cancer, e.g. bowel obstruction found to be due to cancer during surgery.
  • Include patients in whom the pre-operative diagnosis was thought to be cancer, but was subsequently found to be benign disease (ensure the "pathology" variable indicates not cancer; will not be included in primary analysis).
  • Laparoscopic, laparoscopic-converted, robotic, and open cases should be included.
  • Patients aged 18 years and over should be included .
  • Surgery may be with curative or palliative intent. Include patients in whom curative surgery was attempted but abandoned, e.g. open/close laparotomy.

Exclusion Criteria:

  • Operations where breast, gastric, or colorectal cancer is not suspected to be the primary pathology should be excluded.
  • Patients undergoing a procedure purely for diagnosis or staging should be excluded, e.g. open breast biopsy, staging laparoscopy.
  • Patients undergoing a procedure which does not require a skin incision should be excluded, e.g. colonoscopy/endoscopy alone, chemo/radiotherapy alone.
  • Patients presenting with recurrence of breast, colorectal or gastric cancer should be 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
Intervention / Treatment
Breast cancer
Other: Exposure: human development index of country
Primary comparison: Between country groups defined by human development index.
Gastric cancer
Other: Exposure: human development index of country
Primary comparison: Between country groups defined by human development index.
Colon cancer
Other: Exposure: human development index of country
Primary comparison: Between country groups defined by human development index.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
30-day mortality rate
Time Frame: 30 days from surgery
Death within 30 days of surgical procedure
30 days from surgery
30-day complication rate
Time Frame: 30 days from surgery
Defined with by Clavien-Dindo grade III or IV
30 days from surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Availability/performance of pre-operative fine needle aspiration/core biopsy to diagnose breast cancer.
Time Frame: Prior to surgery.
For breast cancer.
Prior to surgery.
Availability/performance of breast/axillary MRI for staging.
Time Frame: Prior to surgery.
For breast cancer.
Prior to surgery.
Availability/performance of breast conservation surgery for AJCC stage 0/I/II breast cancer.
Time Frame: Prior to surgery.
For breast cancer.
Prior to surgery.
Availability/ performance of axillary/breast radiotherapy and axillary lymph node clearance.
Time Frame: Collection of variable within 30 days of surgery.
For breast cancer.
Collection of variable within 30 days of surgery.
Availability/performance of sentinel lymph-node biopsy for early invasive breast cancer.
Time Frame: During surgery.
For breast cancer.
During surgery.
Availability/performance of progesterone receptor (PR), oestrogen receptor (ER), human epidermal growth factor receptor 2 (HER2) receptor and Ki67 status for invasive cancers.
Time Frame: Prior to surgery.
For breast cancer.
Prior to surgery.
Availability/treatment with adjuvant treatment where appropriate within 31 days of completion of surgery.
Time Frame: Within 31 days of completion of surgery.
For breast cancer.
Within 31 days of completion of surgery.
Availability/plan for radiotherapy for all with breast conserving surgery with clear margins (including DCIS).
Time Frame: Collection of variable within 30 days of surgery.
For breast cancer.
Collection of variable within 30 days of surgery.
Margin involvement. "Tumour on inked margin" is considered positive (SSO/ASTRO consensus guidelines) in surgery for early stage breast cancer or a margin <2 mm in DCIS [or ability to measure this locally].
Time Frame: Collection of variable within 30 days of surgery.
For breast cancer.
Collection of variable within 30 days of surgery.
Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging.
Time Frame: Prior to surgery.
For gastric cancer.
Prior to surgery.
Availability/treatment with pre- or post-operative chemotherapy for gastric cancer.
Time Frame: Prior to surgery.
For gastric cancer.
Prior to surgery.
Treatment decisions made within multidisciplinary team meeting / tumour board.
Time Frame: Prior to surgery.
For gastric cancer.
Prior to surgery.
At least 15 regional lymph nodes removed and pathologically examined for resected gastric cancer [or ability to measure this locally].
Time Frame: Collection of variable within 30 days of surgery.
For gastric cancer.
Collection of variable within 30 days of surgery.
Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging.
Time Frame: Prior to surgery.
For colon cancer.
Prior to surgery.
Availability/performance of pre-operative MRI for rectal cancer.
Time Frame: Prior to surgery.
For colon cancer.
Prior to surgery.
Availability/planning/treatment with post-operative chemotherapy following resection for lymph node positive colon cancer.
Time Frame: Collection of variable within 30 days of surgery.
For colon cancer.
Collection of variable within 30 days of surgery.
Availability/treatment with pre-operative chemotherapy/radiotherapy.
Time Frame: Prior to surgery.
For colon cancer.
Prior to surgery.
Treatment decisions made within multidisciplinary team meeting / tumour board.
Time Frame: Prior to surgery.
For colon cancer.
Prior to surgery.
Stoma formation rate.
Time Frame: During surgery.
For colon cancer.
During surgery.
Circumferential resection margin (CRM) >1mm [or ability to measure this locally].
Time Frame: Collection of variable within 30 days of surgery.
For colon cancer.
Collection of variable within 30 days of surgery.
At least 12 regional lymph nodes removed and pathologically examined for resected colon cancer [or ability to measure this locally].
Time Frame: Collection of variable within 30 days of surgery.
For colon cancer.
Collection of variable within 30 days of surgery.

Collaborators and Investigators

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

Sponsor

University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

April 1, 2018

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

April 23, 2019

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

March 19, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Derived anonymised data at the patient-level may be able to be made available for sharing.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

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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