Changes in Taste Perception and Preference in the Peri-operative Patient

NCT ID: NCT02154841

Last Updated: 2014-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Operative Nutrition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Questionnaire, taste test, visual food test

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaire, taste test, visual food test

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital Plymouth NHS Trust

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stephen Lewis, M.B., Ch.B., M.D.

Role: STUDY_DIRECTOR

University Hospital Plymouth NHS Trust

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

Role: PRINCIPAL_INVESTIGATOR

University Hospital Plymouth NHS Trust

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Plymouth Hospitals NHS Trust

Plymouth, Devon, United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

10/H0203/74

Identifier Type: OTHER

Identifier Source: secondary_id

11/P/009

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Usability of myfood24 in Clinical Populations
NCT04758559 COMPLETED EARLY_PHASE1
Food Intake in Older Patients
NCT02490761 COMPLETED
Postoperative Oral Intake Trial
NCT00134407 COMPLETED PHASE1