GlobalSurg 3: Quality and Outcomes in Global Cancer Surgery

Study Overview
=================
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.

Official Title
-----------------
GlobalSurg 3: Quality and Outcomes in Global Cancer Surgery

Conditions
-----------------
Gastric Cancer, Colon Cancer, Breast Neoplasms

Intervention / Treatment
-----------------
* Other: Exposure: human development index of country


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer<br> | Other: Exposure: human development index of country<br>* Primary comparison: Between country groups defined by human development index.<br>|
| Gastric cancer<br> | Other: Exposure: human development index of country<br>* Primary comparison: Between country groups defined by human development index.<br>|
| Colon cancer<br> | Other: Exposure: human development index of country<br>* Primary comparison: Between country groups defined by human development index.<br>|

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. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surgery, Quality, Outcomes