- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07658079
The Effect of the Distance of the Percutaneous Endoscopic Gastrostomy (PEG) Feeding Tube From the Pylorus on Postoperative Outcomes (PEG)
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'.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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. To protect the gastrointestinal mucosa and maintain normal flora, patients should begin enteral nutrition as soon as possible. In patients who cannot 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, is cheaper, and saves time compared to surgical gastrostomy. It was first applied in 1980 as an alternative to surgical gastrostomy. During the procedure, a line was defined between the navel and the middle of the left lower costal margin. A feeding tube was then inserted at the junction of the middle 2/3 and the outer 1/3 under local anesthesia, and feeding was started the following 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) have been described in the literature, with the most common being the "pull" technique. The 2005 ESPEN guidelines noted 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 location 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 achieved through endoscopic transillumination. However, its level within the gastric lumen is predictable. In our study, we aimed to investigate how measuring the distance of the feeding tube from the pylorus in patients undergoing PEG placement affects post-procedure outcomes and to determine the optimal level within the gastric lumen. Additionally, the placement of the catheter on the skin will be recorded in each patient. Traditionally, tube feeding has been delayed until up to 24 hours after percutaneous endoscopic gastrostomy (PEG) procedure. However, results from various randomized controlled trials suggest that early feeding may be an option. A meta-analysis indicated that early feeding (< or = 4 hours) after PEG placement may be a safe alternative to delayed or next-day feeding. However, although there was no difference in overall complications in this meta-analysis, there was a significant increase in gastric residual volume on day 1 in patients who started early feeding. In another meta-analysis conducted by Szary et al., early tube feeding ≤3 hours after PEG placement; Complications, death within ≤72 hours, or significant gastric residual volume on day 1 were found to be significantly different from delayed or next-day feeding. Our study will be the first of its kind in this field. Therefore, to minimize all factors that could negatively affect the results, we will initiate enteral feeding 24 hours after the traditionally used procedure.
Typ studie
Zápis (Odhadovaný)
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
|
Group-1
Shortest tube-to-pylorus distance
|
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-2
Intermediate tube-to-pylorus distance
|
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-3
Greatest tube-to-pylorus distance
|
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'.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Surgery-related complications
Časové okno: From the procedure through the first 2 weeks
|
Incidence of procedure-related and early post-procedure complications
|
From the procedure through the first 2 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Feeding tolerance
Časové okno: Daily monitoring starting 24 hours after the procedure and continuing for the first 2 weeks.
|
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.
|
Daily monitoring starting 24 hours after the procedure and continuing for the first 2 weeks.
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Tube-to-pylorus distance (cm)
Časové okno: At the time of the procedure
|
This is achieved by advancing a marked catheter through the PEG tube immediately after insertion, and simultaneously performing endoscopy.
The distance to the pylorus is measured in centimeters.
|
At the time of the procedure
|
|
PEG tube placement site on the skin
Časové okno: At the time of the procedure
|
Determining PEG localization on the anterior abdominal wall using the xiphoid process, umbilicus, and costal margin as reference points. The anatomical skin localization obtained by examining the data of all patients will be defined as the 'Triangle of Çaykara'. |
At the time of the procedure
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- SisliEtfal-PEG-2026
Informace o lécích a zařízeních, studijní dokumenty
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Studuje produkt zařízení regulovaný americkým úřadem FDA
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