An observational study in Malnutrition, Surgery and Cancer, sponsored by University of Edinburgh. Completed at 11 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-07.
Sponsored by University of Edinburgh · Observational
Aims: The CRANE feasibility study (A mixed methods study of malnutrition and sustainable nutritional intervention for patients undergoing cancer surgery in low- and middle-income countries) aims to investigate the identification of pre-operative malnourishment, data collection methods and acceptability of a nutritional intervention for a future trial to improve outcomes after cancer surgery in low- and middle-income countries (LMICs).
Design: A mixed-methods study comprising of qualitative work including focus groups and interviews, trial of data collection and validation to test feasibility in clinical practice
Participants: Patients undergoing elective surgery for suspected cancer in LMICs
Outcomes Work package (WP) 1: The primary deliverable is the identification of a relevant, pragmatic, and acceptable nutritional screening tool.
WP 2: The primary deliverable is the identification of a low-cost and sustainable nutritional intervention. Focus groups and interviews will be held with patients and clinicians to explore the sustainability, implementation and acceptability of screening and interventions.
WP 3: The primary outcome will be to determine feasibility and acceptability of trial design. A number of outcome assessments and data collection instruments will be evaluated for feasibility, including anthropometric parameters and patient outcomes (30-day mortality, major post-operative complications, length of hospital stay and quality of life). A final study design, analysis plan, and health economic plan will be developed.
Sample size: For this feasibility study, the investigators will conduct multidisciplinary focus groups and interviews, perform and validate malnutrition screening in 200 patients across four countries and record patient 30-day outcomes. This will also include the time taken to collect data on 200 eligible patients. This sample size has been informed from previous malnutrition data originating from a large prospective international multicentre observational cancer study (GlobalSurg 3).
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 168 is below the median of 203 across 388 observational studies indexed under Malnutrition.
Browse Malnutrition studies →University of Edinburgh is the lead sponsor of 393 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing surgery for cancer in four partner LMIC countries are eligible
Exclusion Criteria:
Other: Malnutrition screening
Other: Malnutrition screening
Other: Malnutrition screening
Other: Malnutrition screening
Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer
Prevalence of malnutrition
Malnutrition as measured using validated screening tools
Time frame: Immediately prior to surgery
30-day mortality rate
Death within 30 days of surgical procedure
Time frame: 30 days from surgery
30-day complication rate
Defined with by Clavien-Dindo grade III or IV
Time frame: 30 days from surgery
Length of stay
Length of hospital admission
Time frame: 30 days from surgery
Re-operation rate
Re-operation within 30 days of surgical procedure
Time frame: 30 days from surgery
Quality of life following surgery (EQ-5D-5L / WHODAS questionnaire (36 item))
Short-term quality of life for patients following surgery
Time frame: 30 days from surgery
Readmission rates
Readmission within 30 days of surgery
Time frame: 30 days from surgery
Recruitment rate
Time taken to recruit 200 patients
Time frame: Through study duration, up to one year
Plan to share: Yes — Derived anonymised data at the patient-level may be able to be made available for sharing
Supporting information: Study protocol, Sap, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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University of Edinburgh