Very low-energy diet before surgery in obese patients undergoing partial liver excision: a pilot randomised control trial (Very SuPPLE Trial)

Not Applicable

• Conditions: iver Cancer; Surgery - Other surgery; Obesity; Liver Cancer; Cancer - Liver; Diet and Nutrition - Obesity

• Registration Number: ACTRN12619000680167
• Lead Sponsor: Sydney Local Health District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-07
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

(i)Body Mass Index (BMI) >30 (obese); or a BMI >27 and a waist circumference in obese range (Caucasian – female >88cm, male >102cm; Asian/Aboriginal – female >30cm, male >90cm)
(ii)Undergoing liver resection surgery
(iii)Presenting to an Upper Gastrointestinal surgeon 2 week prior to surgery.

Exclusion Criteria

(i)Clinically malnourished
(ii)Pregnant or breastfeeding
(iii)Have a comorbidity which prohibits restrictive dieting (in consultation with an endocrinologist), or a contra-indication to VLED (eg porphyria, recent myocardial infarction, unstable angina)
(iv)Have a contraindication to (ICG) (iodine hypersensitivity, dialysis, renal failure)
(v)Have cognitive impairment such as they cannot give consent, or
(vi)Have inadequate English language skills to understand the intervention/ study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility:<br>Composite primary outcome, conisisting of feasibility of patients undergoing a two-week trial of VLCD will be assessed by the recruitment, retention and adherence of the participants. The recruitment will be calculated by the number of eligible participants recruited. Retention will be assessed by the proportion of patients in the intervention arm able to complete the intervention and adherence will be calculated by the percentage of the two-week VLCD regimen that was able to be completed from food record diaries.[at end of study period]