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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03471494
Recruitment Status : Unknown
Verified March 2018 by University of Edinburgh.
Recruitment status was:  Not yet recruiting
First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Breast Neoplasms Gastric Cancer Colon Cancer Other: Exposure: human development index of country

Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: GlobalSurg 3: Quality and Outcomes in Global Cancer Surgery
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 30-day mortality rate [ Time Frame: 30 days from surgery ]
    Death within 30 days of surgical procedure

  2. 30-day complication rate [ Time Frame: 30 days from surgery ]
    Defined with by Clavien-Dindo grade III or IV


Secondary Outcome Measures :
  1. Availability/performance of pre-operative fine needle aspiration/core biopsy to diagnose breast cancer. [ Time Frame: Prior to surgery. ]
    For breast cancer.

  2. Availability/performance of breast/axillary MRI for staging. [ Time Frame: Prior to surgery. ]
    For breast cancer.

  3. Availability/performance of breast conservation surgery for AJCC stage 0/I/II breast cancer. [ Time Frame: Prior to surgery. ]
    For breast cancer.

  4. Availability/ performance of axillary/breast radiotherapy and axillary lymph node clearance. [ Time Frame: Collection of variable within 30 days of surgery. ]
    For breast cancer.

  5. Availability/performance of sentinel lymph-node biopsy for early invasive breast cancer. [ Time Frame: During surgery. ]
    For breast cancer.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging. [ Time Frame: Prior to surgery. ]
    For gastric cancer.

  11. Availability/treatment with pre- or post-operative chemotherapy for gastric cancer. [ Time Frame: Prior to surgery. ]
    For gastric cancer.

  12. Treatment decisions made within multidisciplinary team meeting / tumour board. [ Time Frame: Prior to surgery. ]
    For gastric cancer.

  13. 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.

  14. Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging. [ Time Frame: Prior to surgery. ]
    For colon cancer.

  15. Availability/performance of pre-operative MRI for rectal cancer. [ Time Frame: Prior to surgery. ]
    For colon cancer.

  16. 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.

  17. Availability/treatment with pre-operative chemotherapy/radiotherapy. [ Time Frame: Prior to surgery. ]
    For colon cancer.

  18. Treatment decisions made within multidisciplinary team meeting / tumour board. [ Time Frame: Prior to surgery. ]
    For colon cancer.

  19. Stoma formation rate. [ Time Frame: During surgery. ]
    For colon cancer.

  20. Circumferential resection margin (CRM) >1mm [or ability to measure this locally]. [ Time Frame: Collection of variable within 30 days of surgery. ]
    For colon cancer.

  21. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03471494    
Other Study ID Numbers: GS3
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Derived anonymised data at the patient-level may be able to be made available for sharing.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Edinburgh:
Surgery
Quality
Outcomes
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases