POMX (Post Operative Morbidity): randomized controlled trial of chewing gum to reduce postoperative morbidity in elective orthopaedic surgery
| ISRCTN | ISRCTN20301599 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20301599 |
| Secondary identifying numbers | 10666 |
- Submission date
- 29/09/2011
- Registration date
- 29/09/2011
- Last edited
- 03/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gareth Ackland
Scientific
Scientific
Wolfson Institute for Biomedical Research
Gower Street
London
WC1E 6BT
United Kingdom
| g.ackland@ucl.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Not specified |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | POMX (Post Operative Morbidity): randomized controlled trial of chewing gum to reduce postoperative morbidity in elective orthopaedic surgery |
| Study acronym | POM-X |
| Study objectives | 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(s) | 11/H0722/3 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2011 |
| Completion date | 01/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 106; UK Sample Size: 106 |
| Key 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 |
| Key exclusion criteria | 1. Refusal of consent 2. Preoperative nasogastric feeding 3. Gastrostomy feeding 4. Preoperative impaired swallowing |
| Date of first enrolment | 01/09/2011 |
| Date of final enrolment | 01/09/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Wolfson Institute for Biomedical Research
London
WC1E 6BT
United Kingdom
WC1E 6BT
United Kingdom
Sponsor information
University College London (UK)
University/education
University/education
Institute of Ophthalmology
London
WC1E 6BT
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
University/education
Academy of Medical Sciences
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Academy of Medical Sciences
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2015 | Yes | No |
