Contact information
Type
Scientific
Primary contact
Dr Gareth Ackland
ORCID ID
Contact details
Wolfson Institute for Biomedical Research
Gower Street
London
WC1E 6BT
United Kingdom
-
g.ackland@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10666
Study information
Scientific title
POMX (Post Operative Morbidity): randomized controlled trial of chewing gum to reduce postoperative morbidity in elective orthopaedic surgery
Acronym
POM-X
Study hypothesis
Complications following surgery are an important cause of morbidity (illness) and mortality (death). When these complications occur within 30 days of major surgery, long term survival is reduced.
The return of gut movement after elective surgery is important to prevent nausea, vomiting, and abdominal discomfort. Under some circumstances this gut movement is reduced which can lead to delays in oral intake and delayed discharge from hospital. Gastrointestinal dysfunction after surgery is associated with morbidity in other body systems. Chewing-gum is considered a form of 'sham feed' e.g. an imitation of food ingestion. 'Sham-feeding' can help facilitate gut motility by the activation of gastrointestinal hormones.
The POM-X trial is designed to examine if the act of chewing gum following orthopaedic surgery can reduce the incidence of complications postoperatively.
Understanding this mechanism may help us to understand why some patients sustain complications after surgery.
This will allow future clinical care to be guided by an understanding of why these complications arise and allow early detection, treatment and avoidance of postoperative morbidity.
Ethics approval
11/H0722/3
Study design
Randomised; Interventional; Design type: Not specified
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Oral and Gastrointestinal, Generic Health Relevance and Cross Cutting Themes; Subtopic: Oral and Gastrointestinal (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Gastrointestinal, Surgery
Intervention
Clinical assessment, including examination, electrocardiogram (ECG), basic physiological observations
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/2011
Overall trial end date
01/09/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients undergoing elective orthopaedic hip and knee arthroplasty procedures and meet the following criteria:
1. American Society of Anaesthesiologists risk grade 14
2. Age > 40 years
3. Have received a general anaesthetic with/without peripheral nerve block
Target Gender: Male & Female; Upper Age Limit 90 years ; Lower Age Limit 30 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 106; UK Sample Size: 106
Participant exclusion criteria
1. Refusal of consent
2. Preoperative nasogastric feeding
3. Gastrostomy feeding
4. Preoperative impaired swallowing
Recruitment start date
01/09/2011
Recruitment end date
01/09/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wolfson Institute for Biomedical Research
London
WC1E 6BT
United Kingdom
Funders
Funder type
University/education
Funder name
Academy of Medical Sciences
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26323293