EDMONd - Elemental diet in bowel obstruction

EDMONd – A feasibility study of Elemental Diet as an alternative to parenteral nutrition for patients with inoperable Malignant bowel Obstruction

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16862540

Enrollment

Registered

2017-02-20

Start date

2017-03-01

Completion date

Unknown

Last updated

2021-08-24

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

Conditions

Specialty: Cancer, Primary sub-specialty: Gynaecological Cancers

Interventions

All participants receive the Elemental Diet (ED). The ED will be provided in the form of Elemental 028 Extra Liquid. Patients will be assessed by a clinician and specialist oncology dietician and give

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 years and over 2. Confirmed inoperable bowel obstruction due to disseminated malignancy 3. Ability to tolerate 500 ml of liquid 4. Capacity to give informed consent

Exclusion criteria

Exclusion criteria: 1. Bowel obstruction that can be managed with surgical intervention 2. Complete bowel obstruction and inability to tolerate small amount of liquid

Design outcomes

Primary

Measure	Time frame
1. Taste acceptability of ED is measured on 1-5 grading in nutritional diary once per week for two weeks 2. Incidence of vomiting is measured on MSAS scale at day 1 of ED induction, discharge and once per week for two weeks 3. Incidence of pain is measured on MSAS scale at day 1 of ED induction, discharge and once per week for two weeks	—

Secondary

Measure	Time frame
1. The number (proportion) of patient who can tolerate ED following presentation with IBO and can subsequently be treated with palliative chemotherapy is measured by reviewing hospital case notes at patient completion of study 2. The number of patients alive at the end of the study is measured by reviewing hospital case notes at patient completion of study 3. Health Related Quality of Life is measured on EORTC-QLQ-C30 at day 1 of ED induction, discharge and once per week for two weeks 4. Nutritional Intake is measured by the number of ED cartons taken in 24 hours 5. Incidence of vomiting is measured on MSAS scale at day 1 of ED induction, discharge and once per week for two weeks	—

Measure

Time frame

1. The number (proportion) of patient who can tolerate ED following presentation with IBO and can subsequently be treated with palliative chemotherapy is measured by reviewing hospital case notes at patient completion of study 2. The number of patients alive at the end of the study is measured by reviewing hospital case notes at patient completion of study 3. Health Related Quality of Life is measured on EORTC-QLQ-C30 at day 1 of ED induction, discharge and once per week for two weeks 4. Nutritional Intake is measured by the number of ED cartons taken in 24 hours 5. Incidence of vomiting is measured on MSAS scale at day 1 of ED induction, discharge and once per week for two weeks

—

Countries

United Kingdom

Contacts

Public ContactEleanor Smith

eleanor.smith@surrey.ac.uk+44 1483 688547

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 24, 2026