Condition category
Surgery
Date applied
29/09/2011
Date assigned
29/09/2011
Last edited
03/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

University College London (UK)

Sponsor details

Institute of Ophthalmology
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26323293

Publication citations

Additional files

Editorial Notes