Nutrient DeficiencyNCT05110235
PEG Application Experiences to Geriatric Patients
An observational study of Nutrient Deficiency and Gastrostomy, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
Percutaneous endoscopic gastrostomy (PEG) is currently the chosen minimally invasive, endoscopic procedure for medium- and long-term enteral feeding in cases who need palliative care. The presented study evaluated geriatric (> 65-year-old) PEG-applied patients at our institution. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nutrient Deficiency, Gastrostomy
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2017to 30 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: We retrospectively assessed the medical datum of PEG applied >65-year-old patients at our institution between December 2017 and March 2021. And, we excluded the patients who were not treated in our palliative care center. Table 1. shows the contraindications for PEG placement.
Inclusion Criteria: PEG applied >65-year-old patients at our institution between December 2017 and March 2021 -
Exclusion Criteria: We excluded the patients who were not treated in our palliative care center
-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PERCUTANEOUS ENDOSCOPIC GASTROSTOMY APPLICATION EXPERIENCES TO GERIATRIC PATIENTS IN PALLIATIVE CARE UNIT
Percutaneous endoscopic gastrostomy (PEG) is currently the chosen minimally invasive, endoscopic procedure for medium- and long-term enteral feeding in cases who need palliative care. The presented study evaluated geriatric (> 65-year-old) PEG-applied patients at our institution.
Read the detailed description
Palliative care is a treatment method that focuses on the patient and patient's family, aims to minimize the complaints caused by chronic diseases that cannot be treated, and increases life quality. The National Institute for Health and Care Excellence defines palliative care as; the active, holistic care of patients with an advanced progressive illness. Management of pain and other symptoms and providing psychological, social, and spiritual support is paramount. Anorexia, weight loss, and sarcopenia are highly visible and distressing reminders of the life-limiting disease's influence on patients who require palliative care. Given this multifaceted and significant role, it is not unexpected that nutritional treatment method choices can be challenging.
Percutaneous endoscopic gastrostomy (PEG) is a minimally-invasive endoscopic procedure that creates a passage from the patient's stomach to the abdominal wall via a feeding tube and provides a means of feeding if oral intake is not adequate. This safe and effective minimally-invasive option has been utilized in medical practice for over 40 years. PEG has advantages such as being minimally invasive, causing a low rate of complications and morbidity, and providing a long-lasting and safe feeding route. It is currently the chosen procedure for medium- and long-term enteral feeding in cases who need palliative care.
The application of PEG in geriatric-palliative care has not been well discussed. With the development of endoscopic procedures and PEG devices, this minimally invasive method can be applied more safely, even in challenging cases. This study discuss the indications of PEG in the field of palliative care of geriatric patients.
- Conditions
- Nutrient Deficiency, Gastrostomy
- Keywords
- Geriatrics, Nutrition, PEG, Gastrostomy
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin (gr/dl)
30 th day hemoglobin levels after PEG application
Measured: 30 days
Albumin (gr/dl)
30 th day albumin levels after PEG application
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Dec 2017
- Primary completion30 Mar 2021
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrient DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Ferhat Ferhatoglu, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110235
- Sponsor's protocol ID
- 56665618-204.01.08
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERCUTANEOUS ENDOSCOPIC GASTROSTOMY APPLICATION EXPERIENCES TO GERIATRIC PATIENTS IN PALLIATIVE CARE UNIT
- ClinicalTrials.gov ID
- NCT05110235
- Acronym / sponsor ID
- 56665618-204.01.08
- Conditions
- Nutrient Deficiency, Gastrostomy
- Keywords
- Geriatrics, Nutrition, PEG, Gastrostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Percutaneous endoscopic gastrostomy (PEG) is currently the chosen minimally invasive, endoscopic procedure for medium- and long-term enteral feeding in cases who need palliative care. The presented study evaluated geriatric (> 65-year-old) PEG-applied patients at our institution.
Detailed description
Palliative care is a treatment method that focuses on the patient and patient's family, aims to minimize the complaints caused by chronic diseases that cannot be treated, and increases life quality. The National Institute for Health and Care Excellence defines palliative care as; the active, holistic care of patients with an advanced progressive illness. Management of pain and other symptoms and providing psychological, social, and spiritual support is paramount. Anorexia, weight loss, and sarcopenia are highly visible and distressing reminders of the life-limiting disease's influence on patients who require palliative care. Given this multifaceted and significant role, it is not unexpected that nutritional treatment method choices can be challenging.
Percutaneous endoscopic gastrostomy (PEG) is a minimally-invasive endoscopic procedure that creates a passage from the patient's stomach to the abdominal wall via a feeding tube and provides a means of feeding if oral intake is not adequate. This safe and effective minimally-invasive option has been utilized in medical practice for over 40 years. PEG has advantages such as being minimally invasive, causing a low rate of complications and morbidity, and providing a long-lasting and safe feeding route. It is currently the chosen procedure for medium- and long-term enteral feeding in cases who need palliative care.
The application of PEG in geriatric-palliative care has not been well discussed. With the development of endoscopic procedures and PEG devices, this minimally invasive method can be applied more safely, even in challenging cases. This study discuss the indications of PEG in the field of palliative care of geriatric patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We retrospectively assessed the medical datum of PEG applied >65-year-old patients at our institution between December 2017 and March 2021. And, we excluded the patients who were not treated in our palliative care center. Table 1. shows the contraindications for PEG placement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hemoglobin (gr/dl)
Time frame: 30 days
30 th day hemoglobin levels after PEG application
Albumin (gr/dl)
Time frame: 30 days
30 th day albumin levels after PEG application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrient Deficiency and Gastrostomy, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (gr/dl) (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.