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

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: Unknown
• Conditions: Breast Neoplasms; Gastric Cancer; Colon Cancer
• Intervention / Treatment: Other: Exposure: human development index of country

• Study Type: Observational
• Enrollment (Anticipated): 2000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

How is the study designed?

Number of groups / cohorts

3

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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Availability/performance of pre-operative fine needle aspiration/core biopsy to diagnose breast cancer.	For breast cancer.	Prior to surgery.
Availability/performance of breast/axillary MRI for staging.	For breast cancer.	Prior to surgery.
Availability/performance of breast conservation surgery for AJCC stage 0/I/II breast cancer.	For breast cancer.	Prior to surgery.
Availability/ performance of axillary/breast radiotherapy and axillary lymph node clearance.	For breast cancer.	Collection of variable within 30 days of surgery.
Availability/performance of sentinel lymph-node biopsy for early invasive breast cancer.	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.	For breast cancer.	Prior to surgery.
Availability/treatment with adjuvant treatment where appropriate 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).	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].	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.	For gastric cancer.	Prior to surgery.
Availability/treatment with pre- or post-operative chemotherapy for gastric cancer.	For gastric cancer.	Prior to surgery.
Treatment decisions made within multidisciplinary team meeting / tumour board.	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].	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.	For colon cancer.	Prior to surgery.
Availability/performance of pre-operative MRI for rectal cancer.	For colon cancer.	Prior to surgery.
Availability/planning/treatment with post-operative chemotherapy following resection for lymph node positive colon cancer.	For colon cancer.	Collection of variable within 30 days of surgery.
Availability/treatment with pre-operative chemotherapy/radiotherapy.	For colon cancer.	Prior to surgery.
Treatment decisions made within multidisciplinary team meeting / tumour board.	For colon cancer.	Prior to surgery.
Stoma formation rate.	For colon cancer.	During surgery.
Circumferential resection margin (CRM) >1mm [or ability to measure this locally].	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].	For colon cancer.	Collection of variable within 30 days of surgery.

Collaborators and Investigators

• Sponsor: University of Edinburgh

Publications and helpful links

General Publications

• 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. Erratum In: Lancet. 2021 Mar 6;397(10277):880.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2018
• Primary Completion (Anticipated): October 31, 2018
• Study Completion (Anticipated): November 30, 2018

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): March 20, 2018
• Last Update Submitted That Met QC Criteria: March 19, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Surgery; Outcomes; Quality
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• 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