Recruiting

Gastropexy Technique

Sponsor:

CHRISTUS Health

Code:

NCT04096456

Conditions

Gastrostomy

Gastrostomy Complications

Gastrostomy Tube Site Complication

Pain, Postoperative

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Gastrostomy

Gastrostomy Complications

Gastrostomy Tube Site Complication

Pain, Postoperative

Study ID

NCT04096456

Start date

Aug 20, 2015

Status verified date

Jan, 2021

Completion date

Oct 1, 2025

Anticipated

Primary completion date

Oct 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Immediate and Long Term Complications [ Time Frame: The retrospective chart review will include records created starting 01/01/2005 - 06/26/2018. ]

Central Contacts and Locations

Central contacts

Locations

The Children's Hospital of San Antonio

Recruiting

San Antonio, Texas, United States, 78207

Contacts

More Information

Sponsor

CHRISTUS Health

Last update posted

Jan 29, 2021

Last verified

Jan, 2021

Keywords

  • Gastropexy
  • Endoscopic Gastropexy
  • Gastrostomy Tube

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CHRISTUS Health on 2021-01-29.