- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02154841
Changes in Taste Perception and Preference in the Peri-operative Patient (TASTE)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Nutrition is a vital component of good health and recovery from illness. It is particularly clear that patients with chronic diseases and those who have undergone major surgical procedures are vulnerable to the consequences of inadequate calorie or nutritional intake. Over the last decade, surgical practices have evolved to encourage patients to resume early enteral feeding in order to avoid post-operative under-nutrition. Inadequate nutrition has previously been shown to be associated with prolongation of the acute phase response and increased incidence of septic morbidity. More recently clinical studies have demonstrated that early post-operative feeding increases strength and healing of an intestinal anastomosis. Further to this there is also evidence of benefit to patients by reduction of surgical site infections and other complications. Along with the cost saving of a lower complication rate there are financial benefits from reduced mean length of hospital stay.
Over the last 5 years the importance of non-surgical factors in patient recovery or the development of complications has been highlighted. This has resulted in the development and near universal adoption of the 'Enhanced recovery programme (ERP)'. The ERP is a multidisciplinary initiative aiming to improve the patients' journey by:
- Optimizing pre-operative health status
- Reducing postoperative complications and the surgical and physiological stress responses by changing traditional surgical methods
- Early mobility
- Early feeding Post-operative nutrition is a key component to the ERP approach, however, many units that run ERP have reported that encouraging early post operative patients to increase their oral intake is difficult. Our own experience is that dysgeusia (distortion of the sense of taste) is common in the postoperative group.
At present there are no publications in the literature on how best to support the delivery of nutrition to this important group and there is no literature on food preferences in patients who have recently undergone surgery. To date there has not been any research on the subject of peri-operative taste changes outside of surgical fields that directly affect the sensory system of taste (Ear, nose and throat surgery). Although there have been some descriptive studies on calorie intake in the peri-operative period no studies have been performed to confirm the existence of post-operative taste changes or to describe them.
In order to optimise recovery from surgery and as part of the ERP programme, patients should be provided with food choices that encourage greater intake. It is known that optimising early post-operative nutrition will contribute to early discharge and uncomplicated recovery and have knock on benefits for inpatient costs. In order to provide this it is vital that we consider the issue of presumed dysgeusia and its affect on food choices. In order to begin this process the following study is proposed. It is hoped that the results of this study will allow re-evaluation of hospital menus to optimise post-operative nutrition.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Devon
-
Plymouth, Devon, United Kingdom, PL6 8DH
- Plymouth Hospitals NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients who undergo the following laparoscopic procedures
- anterior resection
- right/Left hemicolectomy
- sigmoid colectomy
- abdominal-perineal resection
- stoma formation
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Questionnaire, taste test, visual food test
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To describe taste appreciation and detection in the pre and post-operative Assess taste changes in the peri-operative patient
Time Frame: 3 days post operation
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess taste preferences in the peri-operative patient
Time Frame: 3 days post operation
|
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
|
Patients choice of meal from a selection of photographs of food
Time Frame: 3 days post operation
|
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
|
Collaborators and Investigators
Investigators
- Study Director: Stephen Lewis, M.B., Ch.B., M.D., University Hospital Plymouth NHS Trust
- Principal Investigator: Sophie-Anne Welchman, B.Sc.(Hons), M.B.B.S., University Hospital Plymouth NHS Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 11/P/009
- 10/H0203/74 (Other Identifier: National Research Ethics Service)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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