NCT03471494

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,958

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2019

Completed
Last Updated

June 7, 2024

Status Verified

June 1, 2024

Enrollment Period

7 months

First QC Date

March 9, 2018

Last Update Submit

June 6, 2024

Conditions

Breast NeoplasmsGastric CancerColon Cancer

Keywords

SurgeryQualityOutcomes

Outcome Measures

Primary Outcomes (2)

  • 30-day mortality rate

    Death within 30 days of surgical procedure

    30 days from surgery

  • 30-day complication rate

    Defined with by Clavien-Dindo grade III or IV

    30 days from surgery

Secondary Outcomes (21)

  • Availability/performance of pre-operative fine needle aspiration/core biopsy to diagnose breast cancer.

    Prior to surgery.

  • Availability/performance of breast/axillary MRI for staging.

    Prior to surgery.

  • Availability/performance of breast conservation surgery for AJCC stage 0/I/II breast cancer.

    Prior to surgery.

  • Availability/ performance of axillary/breast radiotherapy and axillary lymph node clearance.

    Collection of variable within 30 days of surgery.

  • Availability/performance of sentinel lymph-node biopsy for early invasive breast cancer.

    During surgery.

  • +16 more secondary outcomes

Study Arms (3)

Breast cancer

Other: Exposure: human development index of country

Gastric cancer

Other: Exposure: human development index of country

Colon cancer

Other: Exposure: human development index of country

Interventions

Exposure: human development index of countryOTHER

Primary comparison: Between country groups defined by human development index.

Breast cancerColon cancerGastric cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Edinburgh

Edinburgh, United Kingdom

Location

Related Publications (2)

  • GlobalSurg Collaborative and National Institute for Health Research Global Health Research Unit on Global Surgery. Global variation in postoperative mortality and complications after cancer surgery: a multicentre, prospective cohort study in 82 countries. Lancet. 2021 Jan 30;397(10272):387-397. doi: 10.1016/S0140-6736(21)00001-5. Epub 2021 Jan 21.

    PMID: 33485461DERIVED

  • NIHR Global Health Research Uniton Global Surgery. Quality and outcomes in global cancer surgery: protocol for a multicentre, international, prospective cohort study (GlobalSurg 3). BMJ Open. 2019 May 24;9(5):e026646. doi: 10.1136/bmjopen-2018-026646.

    PMID: 31129582DERIVED

Related Links

MeSH Terms

Conditions

Breast NeoplasmsStomach NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesColorectal NeoplasmsIntestinal NeoplasmsColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 20, 2018

Study Start

April 1, 2018

Primary Completion

October 31, 2018

Study Completion

April 23, 2019

Last Updated

June 7, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

GB(1)