EDMONd - Elemental diet in bowel obstruction
| ISRCTN | ISRCTN16862540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16862540 |
| ClinicalTrials.gov (NCT) | NCT03150992 |
| Protocol serial number | 32895 |
| Sponsor | Royal Surrey County Hospital NHS Foundation Trust |
| Funder | Target Ovarian Cancer |
- Submission date
- 06/02/2017
- Registration date
- 20/02/2017
- Last edited
- 13/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Contact information
Public
Clinical Trials Office Room 07PGMO2
Department of Microbial & Cellular Sciences
Institute of Biosciences and Medicine
Leggett Building
Faculty of Health and Medical Sciences
Daphne Jackson Road
Guildford
GU2 7WG
United Kingdom
 ORCID ID |
0000-0002-9639-4862 |
|---|---|
| Phone | +44 1483 688547 |
| eleanor.smith@surrey.ac.uk |
Scientific
Department of Clinical and Experimental Medicine
Leggett Building
University of Surrey
Guildford
GU2 7WG
United Kingdom
| ORCID ID |
0000-0002-7262-6227 |
|---|---|
| Phone | +44 (0)1483 688546 |
| a.michael@surrey.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised; Interventional; Design type: Treatment, Dietary |
| Secondary study design | Non randomised study |
| Participant information sheet | ISRCTN16862540_PIS_04Jan17_V2.pdf |
| Scientific title | EDMONd – A feasibility study of Elemental Diet as an alternative to parenteral nutrition for patients with inoperable Malignant bowel Obstruction |
| Study acronym | EDMONd |
| Study objectives | The aim of the study is to provide ‘proof of concept’ of Elemental Diet (ED) as an acceptable/useful feeding option for patients with inoperable bowel obstruction (IBO) and to examine the impact of ED on quality of life. |
| Ethics approval(s) | South East Coast – Surrey Research Ethics Committee, 20/12/2016, ref: 16/LO/2079 |
| Health condition(s) or problem(s) studied | Specialty: Cancer, Primary sub-specialty: Gynaecological Cancers; UKCRC code/ Disease: Cancer/ Malignant neoplasms of female genital organs |
| Intervention | 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 given an individual plan of ED introduction. ED requires phased introduction to achieve tolerance of the course of 3-5 days, under the supervision of the study dietician. Following introduction of ED, patients will be discharged from the hospital (as per normal clinic practise) and followed up for 2 weeks. They will have a telephone follow up assessment once a week for two weeks. All other assessments will follow the standard of care. During the follow up assessment, patients will be assessed using the Memorial Symptom Assessment Scale and asked to complete a nutritional diary and Quality of Life questionnaires. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Taste acceptability of ED is measured on 1-5 grading in nutritional diary once per week for two weeks |
| Key secondary outcome measure(s) |
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 |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 34 |
| Key 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 |
| Key exclusion criteria | 1. Bowel obstruction that can be managed with surgical intervention 2. Complete bowel obstruction and inability to tolerate small amount of liquid |
| Date of first enrolment | 01/03/2017 |
| Date of final enrolment | 28/02/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Guildford
GU2 7XX
United Kingdom
Brighton
BN2 5BE
United Kingdom
London
SE1 9RT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | version V2 | 04/01/2017 | 20/02/2017 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Poster results | results presented in poster at the European Society for Gynaecological Oncology in (ESGO) | 14/12/2020 | 13/08/2021 | No | No |
Additional files
- ISRCTN16862540_PIS_04Jan17_V2.pdf
- Uploaded 20/02/2017
Editorial Notes
13/08/2021: Internal review.
29/04/2021: The scientific contact's details have been updated.
28/04/2021: The following changes have been made:
1. Poster reference added.
2. The intention to publish date has been changed from 31/12/2019 to 28/10/2021.
3. A scientific contact has been added.
26/04/2021: The following changes have been made:
1. The NCT number has been added.
2. Publication reference added.
16/10/2017: Cancer Help UK lay summary link added to plain English summary field
15/09/2017: Internal review.
06/06/2017: Internal review.
27/02/2017: Verified study information with principal investigator.
