Nutrition DisordersNCT05075616
A Retrospective Analysis of Percutaneous Endoscopic Gastrostomy Experiences
An observational study of Nutrition Disorders and Gastrostomy, run by Okan University at 2 sites in Turkey (Türkiye).
Trial summary
The application of PEG in geriatric-palliative care has not been well discussed. With the development of endoscopic procedures and PEG devices, we can perform this minimally invasive method more safely, even in challenging cases. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nutrition Disorders, Gastrostomy
- What is being tested?
- Percutaneous endoscopic gastrostomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 52 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Dec 2017to 1 Mar 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
- Child, Adult, Older adult
Study population: We retrospectively assessed the medical data 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.
Who may be able to join
- We retrospectively assessed the medical datum of PEG applied >65-year-old patients at our institution between December 2017 and March 2021 in our clinic.
Who cannot join
- We excluded the patients who were not treated in our palliative care center.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Okan University Hospital
Istanbul, 34734
Okan University
Istanbul, 34734
About this study
Official title: A Retrospective Analysis of Percutaneous Endoscopic Gastrostomy Application Experiences to Geriatric Patients in Palliative Care Unit
The application of PEG in geriatric-palliative care has not been well discussed. With the development of endoscopic procedures and PEG devices, we can perform this minimally invasive method more safely, even in challenging cases. We should discuss the indications of PEG in the field of palliative care of geriatric patients.
The presented study evaluated geriatric (> 65-year-old) palliative care patients to whom PEG applied 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, we can perform this minimally invasive method more safely, even in challenging cases. We should discuss the indications of PEG in the field of palliative care of geriatric patients.
The presented study evaluated geriatric (> 65-year-old) palliative care patients to whom PEG applied at our institution.
- Conditions
- Nutrition Disorders, Gastrostomy
- Being tested
- Percutaneous endoscopic gastrostomy
- Medical subject headings
- Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous endoscopic gastrostomyProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight and body mass index changes
Evaluation of weight and body mass index changes after Percutaneous endoscopic gastrostomy tube 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 posted13 Oct 2021
- Study start1 Dec 2017
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition DisordersStudies 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
- Investigators
- Murat Ferhat Ferhatoglu, MD, Study director, Okan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075616
- Sponsor's protocol ID
- 08.09.2021/141
- Status last verified
- Oct 2021
- First submitted
- 2 Oct 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Th excel file including study data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of Percutaneous Endoscopic Gastrostomy Application Experiences to Geriatric Patients in Palliative Care Unit
- ClinicalTrials.gov ID
- NCT05075616
- Acronym / sponsor ID
- 08.09.2021/141
- Conditions
- Nutrition Disorders, 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
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 13 Oct 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.
The application of PEG in geriatric-palliative care has not been well discussed. With the development of endoscopic procedures and PEG devices, we can perform this minimally invasive method more safely, even in challenging cases. We should discuss the indications of PEG in the field of palliative care of geriatric patients.
The presented study evaluated geriatric (> 65-year-old) palliative care patients to whom PEG applied 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, we can perform this minimally invasive method more safely, even in challenging cases. We should discuss the indications of PEG in the field of palliative care of geriatric patients.
The presented study evaluated geriatric (> 65-year-old) palliative care patients to whom PEG applied at our institution.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- We retrospectively assessed the medical data 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.
Key inclusion criteria (1 listed)
- We retrospectively assessed the medical datum of PEG applied >65-year-old patients at our institution between December 2017 and March 2021 in our clinic.
Key exclusion criteria (1 listed)
- We excluded the patients who were not treated in our palliative care center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous endoscopic gastrostomyPercutaneous 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. | Procedure or surgery | – |
Primary outcome
Weight and body mass index changes
Time frame: 30 days
Evaluation of weight and body mass index changes after Percutaneous endoscopic gastrostomy tube 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 13 Oct 2021.
- Individual participant dataSharing planned: Undecided. Th excel file including study data will be shared.
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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.
Murat Ferhat Ferhatoglu, MD study director
Okan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition Disorders and Gastrostomy, run by Okan University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Weight and body mass index changes (time frame: 30 days). 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 13 Oct 2021.