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Trial registered on ANZCTR
Registration number
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
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Scientific title
An evaluation of complication rates in percutaneous endoscopic gastrostomy versus nasogastric tube feeding in dysphagic older hospitalized patients
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Secondary ID [1]
282696
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None
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Universal Trial Number (UTN)
U1111-1144-8493
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Trial acronym
PENOH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dysphagia on Older Patients
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Condition category
Condition code
Diet and Nutrition
289735
289735
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0
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Other diet and nutrition disorders
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Oral and Gastrointestinal
289794
289794
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
287365
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Treatment: Devices
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Overall Complication Rate- including procedural complications, pneumonia, missed feeds, hospitalizations, tube dislodgement
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Assessment method [1]
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Timepoint [1]
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4 months
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Secondary outcome [1]
303340
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Procedural complications
-discomfort, dislodged tube, replacement, infection, perforation and any unexpected outcome
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Assessment method [1]
303340
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Timepoint [1]
303340
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4 months
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Secondary outcome [2]
303341
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Hospitalization
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Assessment method [2]
303341
0
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Timepoint [2]
303341
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4 months
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Secondary outcome [3]
303377
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Pneumonia
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Assessment method [3]
303377
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Timepoint [3]
303377
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4 months
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Secondary outcome [4]
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Nutritional Status- assessed with the MNA
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Assessment method [4]
303378
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Timepoint [4]
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4 months
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Secondary outcome [5]
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Mortality- Verified through hospital records and national registry
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Assessment method [5]
303379
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Timepoint [5]
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1 year
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Secondary outcome [6]
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Quality of Life of Patient and Carer- determined by EUROQoL and SF-12 respectively
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Assessment method [6]
303380
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Timepoint [6]
303380
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4 months
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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.
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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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.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation is not done.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/07/2013
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Actual
22/07/2013
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Date of last participant enrolment
Anticipated
30/06/2015
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Actual
30/06/2015
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Date of last data collection
Anticipated
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Actual
30/10/2015
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Sample size
Target
100
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Accrual to date
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Final
102
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Recruitment outside Australia
Country [1]
5152
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Malaysia
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State/province [1]
5152
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Kuala Lumpur
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Funding & Sponsors
Funding source category [1]
287473
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University
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Name [1]
287473
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University of Malaya
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Address [1]
287473
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50603 Kuala Lumpur
Malaysia
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Country [1]
287473
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Malaysia
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Funding source category [2]
295017
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Commercial sector/Industry
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Name [2]
295017
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Halyard Healthcare
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Address [2]
295017
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Tower 2, Wisma AmFirst, Jalan SS7/15 (Jalan Stadium), Kelana Jaya, Petaling Jaya, Selangor 47301
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Country [2]
295017
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Malaysia
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Primary sponsor type
University
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Name
University of Malaya
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Address
Department of Medicine,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
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Country
Malaysia
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Secondary sponsor category [1]
286255
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None
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Name [1]
286255
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Address [1]
286255
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Country [1]
286255
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289451
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Medical Ethics Committee, University Malaya Medical Centre
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Ethics committee address [1]
289451
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Lembah Pantai,
59100 Kuala Lumpur
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Ethics committee country [1]
289451
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Malaysia
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Date submitted for ethics approval [1]
289451
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08/03/2013
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Approval date [1]
289451
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20/03/2013
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Ethics approval number [1]
289451
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974.5
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Tan Maw Pin
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Address
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A/Prof Tan Maw Pin,
Department of Medicine,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
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Country
40814
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Malaysia
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Phone
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+60162066558
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Fax
40814
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Email
40814
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[email protected]
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Contact person for public queries
Name
40815
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Mr Mohamad Hasif Bin Jaafar
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Address
40815
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Mohamad Hasif Bin Jaafar,
Department of Medicine,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
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Country
40815
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Malaysia
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Phone
40815
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+60189630117
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Fax
40815
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Email
40815
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[email protected]
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Contact person for scientific queries
Name
40816
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A/Prof Tan Maw Pin
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Address
40816
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A/Prof Tan Maw Pin,
Department of Medicine,
Faculty of Medicine,
University of Malaya,
50603 Kuala Lumpur
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Country
40816
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Malaysia
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Phone
40816
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+60162066558
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Fax
40816
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Email
40816
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Long-Term Nasogastric Versus Percutaneous Endoscopic Gastrostomy Tube Feeding in Older Asians With Dysphagia: A Pragmatic Study.
2019
https://dx.doi.org/10.1002/ncp.10195
N.B. These documents automatically identified may not have been verified by the study sponsor.
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