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Safety and Efficacy of Endoscopic Assisted Push Gastrostomy Using Gastrostomy Technique

NCT04096456 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2021-01-29

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • CHRISTUS Health

    lead OTHER

Principal Investigators

  • Javier Monagas, MD · The Children's Hospital of San Antonio

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-20
Primary Completion
2025-10-01
Completion
2025-10-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04096456 on ClinicalTrials.gov