NCT02154841

Brief Summary

It is well known that patients who have undergone major surgical procedures are vulnerable to the consequences of inadequate calorie or nutritional intake. Clinical studies have demonstrated that early post-operative feeding increases strength and healing of an intestinal anastomosis, reduces surgical site infection and length of hospital stay. The 'Enhanced recovery programme', ERP, includes early post-operative nutrition as one of its key goals, however there is no guidance on the type of food that should be offered to patients in this programme. Anecdotally, many patients and healthcare professionals believe that there are differences in how food tastes to early post-operative patients. If there are changes in taste following surgery this will affect the food choices that patients make in the early post-operative period. No studies have addressed this question to date. In this study we hope to describe this affect and consider the significance of any changes on the background of current hospital food options. We hypothesise that food preference and tastes and desires are altered in the early post operative period and this affects what patients eat at this critical time.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
Last Updated

June 3, 2014

Status Verified

May 1, 2014

Enrollment Period

1.8 years

First QC Date

May 30, 2014

Last Update Submit

June 2, 2014

Conditions

Keywords

Postoperativenutritiontasteperceptionpreferencechoice

Outcome Measures

Primary Outcomes (1)

  • To describe taste appreciation and detection in the pre and post-operative Assess taste changes in the peri-operative patient

    Patients that agree to participate will complete a questionnaire that asks them about their taste preferences. Recruits will be shown photos of various food stuffs and asked to choose their preferred meal. They will also be asked to put five sponge sticks (a single use item commonly used for mouth care) dipped in one of a five different liquids into their mouths and give their comments what each taste was and on how much they enjoyed it. These five liquids represent the four well-described tastes (sweet, sour, salty, bitter) and a more recently proposed taste, savoury. The intention of this part of the trial is to assess the patient's ability to detect alteration in pure taste and to identify if any of these tastes are preferred.

    3 days post operation

Secondary Outcomes (2)

  • Assess taste preferences in the peri-operative patient

    3 days post operation

  • Patients choice of meal from a selection of photographs of food

    3 days post operation

Study Arms (1)

Questionnaire, taste test, visual food test

EXPERIMENTAL

The participants will complete a questionnaire that asks them about their taste preferences. They will also will be shown photos of various food stuffs and asked to choose their preferred meal. They will also be asked to put five sponge sticks (a single use item commonly used for mouth care) dipped in one of a five different liquids into their mouths and give their comments what each taste was and on how much they enjoyed it. These five liquids represent the four well-described tastes (sweet, sour, salty, bitter) and a more recently proposed taste, savoury. The intention of this part of the trial is to assess the patient's ability to detect alteration in pure taste and to identify if any of these tastes are preferred.

Behavioral: Questionnaire, taste test, visual food test

Interventions

Questionnaire, taste test, visual food test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who undergo the following laparoscopic procedures
  • anterior resection
  • right/Left hemicolectomy
  • sigmoid colectomy
  • abdominal-perineal resection
  • stoma formation

You may not qualify if:

  • The participant may not enter the study if:
  • patients under 18 years old
  • if they report any protracted change in taste over the 6 months prior to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8DH, United Kingdom

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Stephen Lewis, M.B., Ch.B., M.D.

    University Hospital Plymouth NHS Trust

    STUDY DIRECTOR
  • Sophie-Anne Welchman, B.Sc.(Hons), M.B.B.S.

    University Hospital Plymouth NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2014

First Posted

June 3, 2014

Study Start

February 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 3, 2014

Record last verified: 2014-05

Locations