Poor Oral IntakeNCT07658079
The Effect of the Distance of the Percutaneous Endoscopic Gastrostomy (PEG) Feeding Tube From the Pylorus on Postoperative Outcomes
An observational study of Poor Oral Intake and Percutaneous Endoscopic Gastrostomy, run by Sisli Hamidiye Etfal Training and Research Hospital.
Trial summary
Nutrition is the intake of essential nutrients in sufficient quantities and at the appropriate times to maintain and improve health and enhance quality of life. Enteral nutrition is superior to parenteral nutrition and should be preferred. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Poor Oral Intake, Percutaneous Endoscopic Gastrostomy, Nutrition Disorders
- What is being tested?
- Percutaneous endoscopic gastrostomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Aug 2027
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Demographic, clinical, and postoperative data of patients who will undergo PEG procedures in our hospital's surgical endoscopy unit between September 1, 2026, and September 1, 2027, as indicated by neurology, gastroenterology, and intensive care physicians, will be examined.
Who may be able to join
- Over 18 years of age
- No history of major abdominal surgery (appendectomy, hernia, etc.)
- Patients who started feeding 24 hours after the PEG procedure
- Patients not using prokinetic agents.
Who cannot join
- History of stomach, small intestine, large intestine surgery or any history of major abdominal surgery
- Having undergone surgical gastrostomy
- Expected gastroparesis (hemodynamic instability, inotropic support, electrolyte imbalance, etc.)
- Intestinal motility disorder
- Patients who started feeding early
About this study
Nutrition is the intake of essential nutrients in sufficient quantities and at the appropriate times to maintain and improve health and enhance quality of life.
Enteral nutrition is superior to parenteral nutrition and should be preferred. Patients should begin enteral nutrition as soon as possible to protect the gastrointestinal mucosa and maintain normal flora. In patients unable to take food orally, enteral nutrition is provided via a nasogastric/nasojejunal tube or gastrostomy tube.
Read more
Gastrostomy is the first choice for patients with a functional gastrointestinal system, poor oral intake, and requiring long-term nutritional support. Feeding tubes can be placed percutaneously or surgically. Percutaneous endoscopic gastrostomy (PEG) is a minimally invasive procedure that does not increase morbidity or mortality compared to surgical gastrostomy, and is cheaper and more time-saving. It was first applied in 1980 as an alternative to surgical gastrostomy. Initially described, a line was drawn between the umblicus and the middle of the left lower costal margin, and a feeding tube was inserted under local anesthesia at the junction of the middle 2/3 and the outer 1/3, with feeding starting the next day. Vudayagiri et al. reported that the placement site is generally 2 cm medial to the costal margin and 2 cm below the xiphoid process.
Different methods for placing a PEG tube into the stomach (pull technique, push technique, and Russell method) are described in the literature, with the most common being the "pull" technique. The 2005 ESPEN guidelines note that in the "pull" technique, gastroscopic visualization of the anterior gastric wall is performed, followed by determination of the puncture site at the distal corpus level.
The exact placement of the PEG feeding tube, both on the skin and within the gastric lumen, is not fully understood. Its localization on the abdominal skin will be optimally determined by endoscopic transillumination. However, its level within the gastric lumen is predictable.
In our study, we aimed to measure the distance of the feeding tube from the pylorus in patients undergoing PEG surgery, to investigate how this affects post-procedure outcomes, and to determine the optimal level within the gastric lumen. Additionally, the catheter placement on the skin will be recorded for each patient. The anatomical skin localization obtained by examining the data of all patients will be defined as the 'Triangle of Çaykara'.
- Conditions
- Poor Oral Intake, Percutaneous Endoscopic Gastrostomy, Nutrition Disorders, Gastrostomy Tube Site Complication
- Being tested
- Percutaneous endoscopic gastrostomy
- Keywords
- Percutaneous Endoscopic Gastrostomy (PEG), Postoperative Outcomes, feeding tube position, pylorus distance, enteral nutrition, post-procedure complications
- 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
The exact placement of the PEG feeding tube, both on the skin and within the gastric lumen, is not fully understood. In this study, researchers aimed to measure the distance of the feeding tube from the pylorus in patients undergoing PEG surgery, investigate how this affects post-procedure outcomes, and determine the optimal level within the gastric lumen. Additionally, the catheter placement on the skin will be recorded for each patient. The anatomical skin localization obtained by analyzing data from all patients will be defined as the 'Çaykara Triangle'.
| Study group | Role | What they receive |
|---|---|---|
| Group-1 | Shortest tube-to-pylorus distance Receives: Procedure: Percutaneous endoscopic gastrostomy | |
| Group-2 | Intermediate tube-to-pylorus distance Receives: Procedure: Percutaneous endoscopic gastrostomy | |
| Group-3 | Greatest tube-to-pylorus distance Receives: Procedure: Percutaneous endoscopic gastrostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery-related complications
Incidence of procedure-related and early post-procedure complications
Measured: From the procedure through the first 2 weeks
Secondary outcomes (1)
Feeding tolerance
Intolerance to enteral nutrition is typically defined by gastrointestinal symptoms such as vomiting, excessive gastric residual volumes (typically >500 mL over 6 hours), abdominal distension, diarrhea, or constipation. All these parameters will be recorded, but particular attention will be paid to measuring excessive volumes of gastric residue.
Measured: Daily monitoring starting 24 hours after the procedure and continuing for the first 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Oral IntakeStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sinan Ömeroğlu, MD, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07658079
- Sponsor's protocol ID
- SisliEtfal-PEG-2026
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 8 Jul 2026
- 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 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Distance of the Percutaneous Endoscopic Gastrostomy (PEG) Feeding Tube From the Pylorus on Postoperative Outcomes
- ClinicalTrials.gov ID
- NCT07658079
- Acronym / sponsor ID
- SisliEtfal-PEG-2026
- Conditions
- Poor Oral Intake, Percutaneous Endoscopic Gastrostomy, Nutrition Disorders, Gastrostomy Tube Site Complication
- Keywords
- Percutaneous Endoscopic Gastrostomy (PEG), Postoperative Outcomes, feeding tube position, pylorus distance, enteral nutrition, post-procedure complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 18 Jun 2026 (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.
Nutrition is the intake of essential nutrients in sufficient quantities and at the appropriate times to maintain and improve health and enhance quality of life.
Enteral nutrition is superior to parenteral nutrition and should be preferred. Patients should begin enteral nutrition as soon as possible to protect the gastrointestinal mucosa and maintain normal flora. In patients unable to take food orally, enteral nutrition is provided via a nasogastric/nasojejunal tube or gastrostomy tube.
Gastrostomy is the first choice for patients with a functional gastrointestinal system, poor oral intake, and requiring long-term nutritional support. Feeding tubes can be placed percutaneously or surgically. Percutaneous endoscopic gastrostomy (PEG) is a minimally invasive procedure that does not increase morbidity or mortality compared to surgical gastrostomy, and is cheaper and more time-saving. It was first applied in 1980 as an alternative to surgical gastrostomy. Initially described, a line was drawn between the umblicus and the middle of the left lower costal margin, and a feeding tube was inserted under local anesthesia at the junction of the middle 2/3 and the outer 1/3, with feeding starting the next day. Vudayagiri et al. reported that the placement site is generally 2 cm medial to the costal margin and 2 cm below the xiphoid process.
Different methods for placing a PEG tube into the stomach (pull technique, push technique, and Russell method) are described in the literature, with the most common being the "pull" technique. The 2005 ESPEN guidelines note that in the "pull" technique, gastroscopic visualization of the anterior gastric wall is performed, followed by determination of the puncture site at the distal corpus level.
The exact placement of the PEG feeding tube, both on the skin and within the gastric lumen, is not fully understood. Its localization on the abdominal skin will be optimally determined by endoscopic transillumination. However, its level within the gastric lumen is predictable.
In our study, we aimed to measure the distance of the feeding tube from the pylorus in patients undergoing PEG surgery, to investigate how this affects post-procedure outcomes, and to determine the optimal level within the gastric lumen. Additionally, the catheter placement on the skin will be recorded for each patient. The anatomical skin localization obtained by examining the data of all patients will be defined as the 'Triangle of Çaykara'.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group-1 | – | Procedure: Percutaneous endoscopic gastrostomyShortest tube-to-pylorus distance |
| Group-2 | – | Procedure: Percutaneous endoscopic gastrostomyIntermediate tube-to-pylorus distance |
| Group-3 | – | Procedure: Percutaneous endoscopic gastrostomyGreatest tube-to-pylorus distance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Demographic, clinical, and postoperative data of patients who will undergo PEG procedures in our hospital's surgical endoscopy unit between September 1, 2026, and September 1, 2027, as indicated by neurology, gastroenterology, and intensive care physicians, will be examined.
Key inclusion criteria (4 listed)
- Over 18 years of age
- No history of major abdominal surgery (appendectomy, hernia, etc.)
- Patients who started feeding 24 hours after the PEG procedure
- Patients not using prokinetic agents.
Key exclusion criteria (5 listed)
- History of stomach, small intestine, large intestine surgery or any history of major abdominal surgery
- Having undergone surgical gastrostomy
- Expected gastroparesis (hemodynamic instability, inotropic support, electrolyte imbalance, etc.)
- Intestinal motility disorder
- Patients who started feeding early
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 gastrostomyThe exact placement of the PEG feeding tube, both on the skin and within the gastric lumen, is not fully understood. In this study, researchers aimed to measure the distance of the feeding tube from the pylorus in patients undergoing PEG surgery, investigate how this affects post-procedure outcomes, and determine the optimal level within the gastric lumen. Additionally, the catheter placement on the skin will be recorded for each patient. The anatomical skin localization obtained by analyzing data from all patients will be defined as the 'Çaykara Triangle'. | Procedure or surgery | Group-1, Group-2, Group-3 |
Primary outcome
Surgery-related complications
Time frame: From the procedure through the first 2 weeks
Incidence of procedure-related and early post-procedure complications
1 secondary outcome
Feeding tolerance
Time frame: Daily monitoring starting 24 hours after the procedure and continuing for the first 2 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Poor Oral Intake and Percutaneous Endoscopic Gastrostomy, run by Sisli Hamidiye Etfal Training and Research Hospital.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Surgery-related complications (time frame: From the procedure through the first 2 weeks). 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 8 Jul 2026.