Safety and Efficacy of Endoscopic Assisted Push Gastrostomy Using Gastrostomy Technique

Pain, Postoperative Clinical Trial

Official title:

Safety and Efficacy of Endoscopic Assisted Push Gastrostomy Using Gastropexy Technique

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04096456
• Other study ID #: H-37260
• Status: Recruiting
• Start date: August 20, 2015
• Est. completion date: October 1, 2025

Study information

• Verified date: January 2021
• Source: CHRISTUS Health
• Contact: Javier Monagas, MD
• Phone: 210-704-4849
• Email: monagas[@]bcm.tmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Most pediatric gastroenterologists use an endoscopic pull technique to place gastrostomy tubes. We assessed an endoscopic gastropexy technique for gastrostomy tube placement that allows immediate placement of a low profile gastrostomy tube or gastro-jejunostomy tube. The procedure involves endoscopy with the placement of three T-fasteners that are placed through the skin into the stomach, placating and securing the stomach to the abdominal wall. This attachment process promotes formation of a stable gastrostomy tract, facilitating an immediate placement of a low profile gastrostomy button or gastro-jejunostomy tube. Serial dilators are then used to obtain the desired diameter of the ostomy for the tube placement. The gastropexy technique is most often associated with laparoscopic procedures involving gastric volvulus or complicated GERD, but little has been published investigating the outcomes of pediatric gastrostomy tube placement with the use of the gastropexy technique.

Description:

This is a retrospective chart review. We will review charts of patients who underwent gastrostomy with gastropexy and primary percutaneous gastrostomy tube placement with pull through technique and compare immediate complications such as (pain, bleeding, and infection), and long term complications such as (feeding problems, pain, death, infection, bleeding and granulation), and for readmission in the 3 months following placement. Our control group will be the patients with primary percutaneous gastrostomy tube placement with pull through technique compared to the outcomes of the gastrostomy with gastropexy patients.

Inclusion Criteria:

Inclusion criteria is pediatric patients requiring an alternate means of nutrition with gastrostomy placement. Subjects ages 0-17 years of age. Data created starting 01/01/2005 to 07/31/2015.

Exclusion Criteria:

Patients that do not meet inclusion criteria.

Procedures: Most pediatric gastroenterologists use an endoscopic pull technique to place gastrostomy tubes. We will assess an endoscopic gastropexy technique for gastrostomy tube placement that allows immediate placement of a low profile gastrostomy tube or gastro-jejunostomy tube. The procedure involves endoscopy with the placement of three T-fasteners that are placed through the skin into the stomach, placating and securing the stomach to the abdominal wall. This attachment process promotes formation of a stable gastrostomy tract, facilitating an immediate placement of a low profile gastrostomy button or gastro-jejunostomy tube. Serial dilators are then used to obtain the desired diameter of the ostomy for the tube placement and a low profile gastrostomy button of appropriate size is placed. We will review complications both long term and short term of both the primary percutaneous gastrostomy tube placement with pull through technique compared to the outcomes of the gastrostomy with gastropexy patients.

Screening of GI cases at the Children's Hospital of San Antonio will be performed by PI and research staff to identify eligible patients. The subject record will be accessed and data recorded. The information recorded will be coded in the event a subject record requires subsequent reviews to obtain data. The subject record will be coded in order to protect subject PHI confidential. Please see section S for the data collection tool. The chart review will include records created starting 01/01/2005 - 06/26/2018.

Sample size: Local: 150, Worldwide: 150 The sample size is the any patient who underwent a gastrostomy with gastropexy or primary percutaneous gastrostomy tube placement with pull through technique by the gastroenterologists at the Children's Hospital of San Antonio.

Data Analysis: The primary comparison is the difference between immediate complications such as (pain, bleeding, and infection), and long term complications such as (feeding problems, pain, death, infection, bleeding and granulation) to evaluate efficacy and safety of gastrostomy with gastropexy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

• Inclusion criteria is pediatric patients requiring an alternate means of nutrition with gastrostomy placement. Subjects ages 0-17 years of age. Data created starting 01/01/2005 to 07/31/2015.

Exclusion Criteria:

• Patients that do not meet inclusion criteria.

Related Conditions & MeSH terms

• Gastrostomy
• Gastrostomy Complications
• Gastrostomy Tube Site Complication
• Pain, Postoperative

Locations

Country	Name	City	State
United States	The Children's Hospital of San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
CHRISTUS Health	Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate and Long Term Complications	The primary comparison is the difference between immediate complications such as (pain, bleeding, and infection), and long term complications such as (feeding problems, pain, death, infection, bleeding and granulation) to evaluate efficacy and safety of gastrostomy with gastropexy.	The retrospective chart review will include records created starting 01/01/2005 - 06/26/2018.