Preoperative exclusive enteral nutrition versus usual care in Crohn's disease

Not Applicable

Recruiting

• Conditions: Crohn's disease; Surgery - Other surgery; Oral and Gastrointestinal - Crohn's disease

• Registration Number: ACTRN12621000002886
• Lead Sponsor: niversity of Otago

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-07
• Last Update Posted: 12 April 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Adults over 16 years old with diagnosed Crohn's disease who have consented to have elective gastrointestinal resection for the management of Crohn's disease.

Exclusion Criteria

Patients with Crohn’s disease requiring emergency surgery or surgery within 6 weeks
Currently has a stoma – may affect study outcomes
Requires pre-operative parenteral nutrition. This patient group are unlikely to tolerate the
usual care intervention
Patients at high risk of malnutrition defined as BMI < 18.5 and greater than 10% body weight
loss in last 6 months – malnutrition independently affects surgical outcomes.
Patients who cannot attend the baseline and pre-surgical assessment appointments – this
would result in incomplete secondary outcomes data collection
Does not speak English

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether it is feasible to recruit patients with Crohn’s disease undergoing gastrointestinal surgery in a single-blinded RCT to compare enteral nutrition treatments and standard care. <br>This will be assessed by calculating the recruitment rate (comparing the number of potentially eligible patients to the number of patients recruited) . [20 months after first participant enrolled];To determine retention rate to the study intervention arms.<br>This will be assessed by calculating the number of patients enrolled in each arm of the study compared to the number who complete the intervention period. [20 months after enrolment of first participant.];To determine whether it is feasible to collect the planned primary and secondary effectiveness objectives. This will be assessed by calculating the proportion of patients who completed each outcome at each of the three time points. [20 months after enrolment of first participant]