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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast cancer |
| ||
| Gastric cancer |
| ||
| Colon cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure: human development index of country | Other | Primary comparison: Between country groups defined by human development index. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing elective or emergency surgery for breast, gastric, or colorectal cancer anywhere in the world are eligible.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Edinburgh | Edinburgh | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33485461 | Derived | 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. | |
| 31129582 |
| Label | URL |
|---|---|
| Related Info | View source |
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Derived anonymised data at the patient-level may be able to be made available for sharing.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D013274 | Stomach Neoplasms |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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. |
| 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. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |