Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04096456 |
Other study ID # |
H-37260 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.