Status:
WITHDRAWN
Preoperative Very Low Energy Diet for Obese Rectal Cancer Patients
Lead Sponsor:
McMaster University
Conditions:
Rectal Cancer
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This pilot study will aim to determine the feasibility, safety, and cost associated with a preoperative VLED for obese rectal cancer patients. Ultimately, the investigators seek to provide evidence th...
Detailed Description
This study is a single center, single-arm prospective cohort pilot study with a primary aim of determining the feasibility, safety, and cost associated with a preoperative VLED for obese rectal cancer...
Eligibility Criteria
Inclusion
- 18 years of age or older
- BMI greater than or equal to 30kg/m2 and less than or equal to 55kg/m2
- Patients undergoing elective surgery
- Documented pathological diagnosis of rectal adenocarcinoma
- Preoperative staging investigations consistent with stage I, II, and III disease
- Laparoscopic surgery occurring at St. Joseph's Healthcare Hamilton
Exclusion
- BMI less than 30kg/m2
- Contraindications to magnetic resonance imaging, general anesthesia, or major colorectal surgery
- Patient undergoing open surgery
- Patients undergoing emergency or palliative surgery
- Preoperative staging investigations consistent with metastatic disease
- Allergy or contraindication to the use of Optifast
- Prior pelvic colorectal surgery or bariatric surgery
- Enrolled in any other clinical trials or prospective studies where similar outcomes are measured
- Severe, chronic cardiovascular disease (i.e. recent myocardial infarction, unstable angina), renal disease, or hepatic dysfunction
- Patients with pharmacologically managed diabetes mellitus
- Pregnant and/or breastfeeding patients
- Inability to provide informed consent
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04379830
Start Date
August 1 2022
End Date
June 30 2023
Last Update
January 5 2024
Active Locations (1)
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1
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6