NCT07658079

Brief 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. 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'.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started Aug 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Last Updated

July 8, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

June 14, 2026

Last Update Submit

July 4, 2026

Conditions

Keywords

Percutaneous Endoscopic Gastrostomy (PEG)Postoperative Outcomesfeeding tube positionpylorus distanceenteral nutritionpost-procedure complications

Outcome Measures

Primary Outcomes (1)

  • Surgery-related complications

    Incidence of procedure-related and early post-procedure complications

    From the procedure through the first 2 weeks

Secondary Outcomes (1)

  • Feeding tolerance

    Daily monitoring starting 24 hours after the procedure and continuing for the first 2 weeks.

Other Outcomes (2)

  • Tube-to-pylorus distance (cm)

    At the time of the procedure

  • PEG tube placement site on the skin

    At the time of the procedure

Study Arms (3)

Group-1

Shortest tube-to-pylorus distance

Procedure: Percutaneous endoscopic gastrostomy

Group-2

Intermediate tube-to-pylorus distance

Procedure: Percutaneous endoscopic gastrostomy

Group-3

Greatest tube-to-pylorus distance

Procedure: Percutaneous endoscopic gastrostomy

Interventions

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'.

Group-1Group-2Group-3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nutrition Disorders

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
14 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof. Dr. Sinan Ömeroğlu, MD, PhD

Study Record Dates

First Submitted

June 14, 2026

First Posted

June 18, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Last Updated

July 8, 2026

Record last verified: 2026-06