EDMONd - Elemental diet in bowel obstructio

Not Applicable

Completed

• Conditions: Specialty: Cancer, Primary sub-specialty: Gynaecological Cancers; UKCRC code/ Disease: Cancer/ Malignant neoplasms of female genital organs; Cancer; Ovarian cancer

• Registration Number: ISRCTN16862540
• Lead Sponsor: Royal Surrey County Hospital NHS Foundation Trust

Brief Summary

2020 Poster results in https://doi.org/10.26226/morressier.5fa3ee5d55b1fd4cc4dd9427 results presented in poster at the European Society for Gynaecological Oncology in (ESGO) (added 13/08/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-20
• Study Completion: 2019-12-31
• Last Update Posted: 24 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 2. The number of patients alive at the end of the study is measured by reviewing hospital case notes at patient completion of study<br> 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<br> 4. Nutritional Intake is measured by the number of ED cartons taken in 24 hours<br> 5. Incidence of vomiting is measured on MSAS scale at day 1 of ED induction, discharge and once per week for two weeks<br>