Safety and Efficacy of Endoscopic Assisted Push Gastrostomy Using Gastrostomy Technique
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 20, 2015
CompletedFirst Submitted
Initial submission to the registry
September 18, 2019
CompletedFirst Posted
Study publicly available on registry
September 19, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2025
CompletedJanuary 29, 2021
January 1, 2021
10.1 years
September 18, 2019
January 26, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHRISTUS Healthlead
- Baylor College of Medicinecollaborator
Study Sites (1)
The Children's Hospital of San Antonio
San Antonio, Texas, 78207, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Javier Monagas, MD
The Children's Hospital of San Antonio
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2019
First Posted
September 19, 2019
Study Start
August 20, 2015
Primary Completion
October 1, 2025
Study Completion
October 1, 2025
Last Updated
January 29, 2021
Record last verified: 2021-01