- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04096456
Safety and Efficacy of Endoscopic Assisted Push Gastrostomy Using Gastrostomy Technique
Safety and Efficacy of Endoscopic Assisted Push Gastrostomy Using Gastropexy Technique
Study Overview
Status
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Javier Monagas, MD
- Phone Number: 210-704-4849
- Email: monagas@bcm.tmc.edu
Study Contact Backup
- Name: James Noel, MD
- Phone Number: 210-704-4849
- Email: jmnoel@bcm.tmc.edu
Study Locations
-
-
Texas
-
San Antonio, Texas, United States, 78207
- Recruiting
- The Children's Hospital of San Antonio
-
Contact:
- Javier Monagas, MD
- Phone Number: 210-704-2686
- Email: javier.monagas@christushealth.org
-
Contact:
- James Noel, MD
- Phone Number: 210-704-2686
- Email: james.noel@christushealth.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immediate and Long Term Complications
Time Frame: The retrospective chart review will include records created starting 01/01/2005 - 06/26/2018.
|
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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Javier Monagas, MD, The Children's Hospital of San Antonio
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-37260
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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