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Trial registered on ANZCTR


Trial ID
ACTRN12613000713796
Ethics application status
Approved
Date submitted
21/06/2013
Date registered
28/06/2013
Date last updated
21/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
PENOH - Percutaneous Endoscopic Gastrostomy versus Nasogastric Tube Feeding in Older Hospitalized Patients
Scientific title
An evaluation of complication rates in percutaneous endoscopic gastrostomy versus nasogastric tube feeding in dysphagic older hospitalized patients
Secondary ID [1] 282696 0
None
Universal Trial Number (UTN)
U1111-1144-8493
Trial acronym
PENOH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysphagia on Older Patients 289410 0
Condition category
Condition code
Diet and Nutrition 289735 289735 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 289794 289794 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Percutaneous Endoscopic Gastrostomy - A feeding tube is inserted through the skin on the abdominal wall into the stomach with the aid of an endoscope which is inserted into the stomach for direct visualization of the procedure. The patient usually needs light sedation and local anaesthetic. The intervention will continue for as long as required by the patient. Patients will choose to have a PEG inserted for feeding purposes or whether to stay in NG feeding. Patients will be recruited if they are judged to require enteral feeding for a minimum of 6 weeks.
Intervention code [1] 287365 0
Treatment: Devices
Comparator / control treatment
Nasogastric tube feeding - A finebore nasogastric feeding tube is inserted via the nostril through the nasopharynx, oropharynx and oesophagus into the stomach. The patient is asked to swallow during this procedure to aid the introduction of the feeding tube. NG feeding will continue for as long as clinically required. Patients will choose to have a PEG inserted for feeding purposes or whether to stay in NG feeding. Patients will be recruited if they are judged to require enteral feeding for a minimum of 6 weeks.
Control group
Active

Outcomes
Primary outcome [1] 289831 0
Overall Complication Rate- including procedural complications, pneumonia, missed feeds, hospitalizations, tube dislodgement
Timepoint [1] 289831 0
4 months
Secondary outcome [1] 303340 0
Procedural complications
-discomfort, dislodged tube, replacement, infection, perforation and any unexpected outcome
Timepoint [1] 303340 0
4 months
Secondary outcome [2] 303341 0
Hospitalization
Timepoint [2] 303341 0
4 months
Secondary outcome [3] 303377 0
Pneumonia
Timepoint [3] 303377 0
4 months
Secondary outcome [4] 303378 0
Nutritional Status- assessed with the MNA
Timepoint [4] 303378 0
4 months
Secondary outcome [5] 303379 0
Mortality- Verified through hospital records and national registry
Timepoint [5] 303379 0
1 year
Secondary outcome [6] 303380 0
Quality of Life of Patient and Carer- determined by EUROQoL and SF-12 respectively
Timepoint [6] 303380 0
4 months

Eligibility
Key inclusion criteria
- Patients have to be 65 years old and above with a diagnosis of dysphagia.

- Recommended for long term nutritional support via the enteral route.

- Likely to require artificial feeding for at least 6 weeks.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients had contraindications to either NG feeding or PEG feeding.

- Terminal phase of illness, acute gastrointestinal haemorrhage, acute coronary syndrome and end-stage dementia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
100 patients and their carers will be approached to participate in the study once identified by their physician as suitable. They will be provided with information about the study and a contact number and a further appointment made for 24 hours later for the consent process. Consent will be sought from the patients or the next-of-kin.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation is not done.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Baseline characteristics were analyzed by using the Independent t-test, after the Shapiro-Wilk normality testing indicated a good fit (p-value >0.05). Non-normally distributed data were compared using the Mann-Whitney U test and categorical data with the Chi-squared test. Complication rates were compared at three weeks, two months and four months using the Chi-squared test and adjusted for potential confounders using logistic regression. Missing values were replaced by using the last observation carried forward (LOCF) method. Intention-to-treat analysis was performed for the composite outcome of mortality and any complication.
Nutritional outcomes were assessed only in those patients with a minimum period of follow-up of four months. An independent t-test was used to compare findings between differing groups, with p-value <0.05 considered statistically significant. For within group analysis, baseline and 4 month post tube insertion data were compared using a paired t-test. Missing data were only replaced for those lost to follow-up using multiple imputation and linear interpolation19.
A Kaplan-Meier survival analysis and the Log-Rank test were used to compare survival between the NG group and PEG group. The Cox-regression model was then used to determine the effect of tube feeding on survival controlling for differences in the co-variables at baseline. To determine differences in time to first hospitalization and death, sets of similar survival analyses were performed using the Cox-regression method.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5152 0
Malaysia
State/province [1] 5152 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 287473 0
University
Name [1] 287473 0
University of Malaya
Address [1] 287473 0
50603 Kuala Lumpur
Malaysia
Country [1] 287473 0
Malaysia
Funding source category [2] 295017 0
Commercial sector/Industry
Name [2] 295017 0
Halyard Healthcare
Address [2] 295017 0
Tower 2, Wisma AmFirst, Jalan SS7/15 (Jalan Stadium), Kelana Jaya, Petaling Jaya, Selangor 47301
Country [2] 295017 0
Malaysia
Primary sponsor type
University
Name
University of Malaya
Address
Department of Medicine,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 286255 0
None
Name [1] 286255 0
Address [1] 286255 0
Country [1] 286255 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289451 0
Medical Ethics Committee, University Malaya Medical Centre
Ethics committee address [1] 289451 0
Lembah Pantai,
59100 Kuala Lumpur
Ethics committee country [1] 289451 0
Malaysia
Date submitted for ethics approval [1] 289451 0
08/03/2013
Approval date [1] 289451 0
20/03/2013
Ethics approval number [1] 289451 0
974.5

Summary
Brief summary
This study will explore the potential use of PEG feeding in dysphagic older people requiring artificial feeding for a variety of medical conditions in an Asian population. A study exploring long term nutritional support in the elderly population such as this will have important implications for the care of older people in developing countries as it contributes significantly to the socioeconomic burdens of these countries.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40814 0
A/Prof Tan Maw Pin
Address 40814 0
A/Prof Tan Maw Pin,
Department of Medicine,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country 40814 0
Malaysia
Phone 40814 0
+60162066558
Fax 40814 0
Email 40814 0
mptan@ummc.edu.my
Contact person for public queries
Name 40815 0
Mr Mohamad Hasif Bin Jaafar
Address 40815 0
Mohamad Hasif Bin Jaafar,
Department of Medicine,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country 40815 0
Malaysia
Phone 40815 0
+60189630117
Fax 40815 0
Email 40815 0
hasifjaafar@siswa.um.edu.my
Contact person for scientific queries
Name 40816 0
A/Prof Tan Maw Pin
Address 40816 0
A/Prof Tan Maw Pin,
Department of Medicine,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
Country 40816 0
Malaysia
Phone 40816 0
+60162066558
Fax 40816 0
Email 40816 0
mptan@ummc.edu.my