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Safety and Efficacy of Endoscopic Assisted Push Gastrostomy Using Gastrostomy Technique

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ClinicalTrials.gov Identifier: NCT04096456
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : January 29, 2021
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
CHRISTUS Health

Brief 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.

Condition or disease
Gastrostomy Gastrostomy Complications Gastrostomy Tube Site Complication Pain, Postoperative

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Safety and Efficacy of Endoscopic Assisted Push Gastrostomy Using Gastropexy Technique
Actual Study Start Date : August 20, 2015
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Retrospective chart review. The study population includes 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 from 01/01/2005 - 06/26/2018.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096456


Contacts
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Contact: Javier Monagas, MD 210-704-4849 monagas@bcm.tmc.edu
Contact: James Noel, MD 210-704-4849 jmnoel@bcm.tmc.edu

Locations
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United States, Texas
The Children's Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
Contact: Javier Monagas, MD    210-704-2686    javier.monagas@christushealth.org   
Contact: James Noel, MD    210-704-2686    james.noel@christushealth.org   
Sponsors and Collaborators
CHRISTUS Health
Baylor College of Medicine
Investigators
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Principal Investigator: Javier Monagas, MD The Children's Hospital of San Antonio
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Responsible Party: CHRISTUS Health
ClinicalTrials.gov Identifier: NCT04096456    
Other Study ID Numbers: H-37260
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHRISTUS Health:
Gastropexy
Endoscopic Gastropexy
Gastrostomy Tube
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations