Pre-operative Very Low Energy Diet in Laparoscopic Surgery: A Pilot Study

Effect of Very Low Energy Diet (VLED) on Pre-Operative Weight Loss in Laparoscopic Colorectal Surgery: A Pilot Study

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000796189

Enrollment

Registered

2019-05-30

Start date

2021-02-01

Completion date

2022-02-01

Last updated

2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is a pilot study looking at the efficacy and feasibility of pre-operative very low energy diet in patients with BMI greater than 30, prior to laparoscopic colorectal study. Participants will be prescribed the Optifast Intensive Program on a daily basis after enrolment in the study and will take the Optifast meal replacement until the day of surgery.

Interventions

The VLED used in this study will be the Optifast intensive program. This consists of 3 to 5 Optifast shakes (dependent on body weight) daily, in addition to two cups of low-starch vegetables, plus one teaspoon of vegetable oil. A protein target of 0.75g/kg of actual body weight will be achieved through the Optifast shakes, with the addition of Beneprotein supplementation if necessary. The Optifast and Beneprotein will be administered by the dietician and will be provided to the participant for the duration of the study. The duration of VLED will be from commencement of the study to date of surgery, this will be a maximum of 4 weeks. A combination of daily food diary and weekly telephone call from the dietician will be used to monitor adherence to the VLED.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

BMI greater than 30 Undergoing elective laparoscopic colorectal procedure

Exclusion criteria

Unable to give consent Unintentional loss of weight greater than 5% of body weight in the last six months Insulin-dependent diabetes mellitus Congestive heart failure requiring diuretic therapy Stage 3 chronic kidney disease Child's Pugh B or C chronic liver disease

Outcome results