GlobalSurg 3: Quality and Outcomes in Global Cancer Surgery

Gastric Cancer Clinical Trial

— GS3  

Official title:

GlobalSurg 3: Quality and Outcomes in Global Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03471494
• Other study ID #: GS3
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: April 23, 2019

Study information

• Verified date: June 2024
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15958
• Est. completion date: April 23, 2019
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Colon Cancer
• Gastric Cancer

Intervention

Other:
• Exposure: human development index of country
Primary comparison: Between country groups defined by human development index.

Locations

Country	Name	City	State
United Kingdom	University of Edinburgh	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality rate	Death within 30 days of surgical procedure	30 days from surgery
Primary	30-day complication rate	Defined with by Clavien-Dindo grade III or IV	30 days from surgery
Secondary	Availability/performance of pre-operative fine needle aspiration/core biopsy to diagnose breast cancer.	For breast cancer.	Prior to surgery.
Secondary	Availability/performance of breast/axillary MRI for staging.	For breast cancer.	Prior to surgery.
Secondary	Availability/performance of breast conservation surgery for AJCC stage 0/I/II breast cancer.	For breast cancer.	Prior to surgery.
Secondary	Availability/ performance of axillary/breast radiotherapy and axillary lymph node clearance.	For breast cancer.	Collection of variable within 30 days of surgery.
Secondary	Availability/performance of sentinel lymph-node biopsy for early invasive breast cancer.	For breast cancer.	During surgery.
Secondary	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.
Secondary	Availability/treatment with adjuvant treatment where appropriate within 31 days of completion of surgery.	For breast cancer.	Within 31 days of completion of surgery.
Secondary	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.
Secondary	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.
Secondary	Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging.	For gastric cancer.	Prior to surgery.
Secondary	Availability/treatment with pre- or post-operative chemotherapy for gastric cancer.	For gastric cancer.	Prior to surgery.
Secondary	Treatment decisions made within multidisciplinary team meeting / tumour board.	For gastric cancer.	Prior to surgery.
Secondary	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.
Secondary	Availability/performance of CT chest, abdomen and pelvis scan performed for pre-operative staging.	For colon cancer.	Prior to surgery.
Secondary	Availability/performance of pre-operative MRI for rectal cancer.	For colon cancer.	Prior to surgery.
Secondary	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.
Secondary	Availability/treatment with pre-operative chemotherapy/radiotherapy.	For colon cancer.	Prior to surgery.
Secondary	Treatment decisions made within multidisciplinary team meeting / tumour board.	For colon cancer.	Prior to surgery.
Secondary	Stoma formation rate.	For colon cancer.	During surgery.
Secondary	Circumferential resection margin (CRM) >1mm [or ability to measure this locally].	For colon cancer.	Collection of variable within 30 days of surgery.
Secondary	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.

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