Treatment for Gastrostomy Complications

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Phoenix Children's, Phoenix, AZ
Gastrostomy Complications
Eligibility
< 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new securement device for gastrostomy tubes can reduce complications.

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Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 1 primary outcome and 1 secondary outcome in patients with Gastrostomy Complications. Measurement will happen over the course of entire study (3 months after placement).

Month 3
Caregiver Strain Index
Reduction in G-button complications

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Standard Dressing
1 of 1
Active Control

This trial requires 200 total participants across 1 different treatment group

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Standard DressingSubjects will be provided instructions and a 12-week supply of tape and gauze (current standard of care), sufficient to change the gauze dressing at least once per day.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: entire study (3 months after placement)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly entire study (3 months after placement) for reporting.

Closest Location

Phoenix Children's - Phoenix, AZ

Eligibility Criteria

This trial is for patients born any sex aged 65 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients who are hospitalized for any reason and have a pre-existing G-button will be eligible for the study if they experience any complications with their current G-button site. show original
Patients aged 31 days to 18 years old who require a gastrostomy button for surgical placement can have the procedure done open, endoscopically, or laparoscopically. show original
Any patient who has a G-button and needs it replaced or who has complications associated with the G-button will be seen at the G-button or surgery clinic. show original

Patient Q&A Section

How many people get gastrostomy complications a year in the United States?

"The American Gastrostomy Association reports that approximately 1 in every 25 individuals who have undergone a G-tube placement will develop a gastrostomy related complication; of those, as many as 20 percent of them will require reoperation for gastric prolapse. The morbidity and cost associated with G-tube placement has become a significant source of health care utilization by the American population. Despite the growing number of patients and indications for such procedures, gastrostomy-related complications remain infrequent. However, they still pose significant challenges to patients and health professionals. Current studies suggest that the incidence of serious complications is still much higher than it was 10 years ago. Therefore, it is critical to develop enhanced protocols that reduce the time until a reoperation." - Anonymous Online Contributor

Unverified Answer

What causes gastrostomy complications?

"There are various factors that can influence gastro-oesophageal reflux. A few key questions and a simple assessment can serve as helpful tools against reflux and gastrostomy complications." - Anonymous Online Contributor

Unverified Answer

What is gastrostomy complications?

"Complications during gastrostomy insertion are common but only a minority of which can be avoided. The risk should be discussed with the patient and family before the procedure." - Anonymous Online Contributor

Unverified Answer

What are common treatments for gastrostomy complications?

"Gastrostomy is commonly performed to facilitate nutritional support for patients on aggressive feeding regimens for more than 2 months. A variety of techniques and devices have been used, but most recent devices simplify the procedure. The complication rate is low, and gastrostomy is very effective in obtaining a more natural eating experience in patients with short-term feeding needs." - Anonymous Online Contributor

Unverified Answer

What are the signs of gastrostomy complications?

"The most common complication of gastrostomy placement is displacement of the tube, which often occurs within 24 hours of its placement. Abdominal complaints such as pain, bloating or distension can be an important clue to the presence of a gastrostomy tube in the abdomen and the need for intervention. Additional signs of complications include abnormal post-prandial gastric emptying and delayed gastric emptying and can be signs of vomiting. Pyloric outlet obstruction is frequently an asymptomatic finding of the gastrostomy. In an otherwise healthy, fully ambulatory young patient, these indications would warrant further investigations and hospital admission, and warrant immediate gastrostomy tube removal and appropriate interventions if confirmed by upper GI fluoroscopy." - Anonymous Online Contributor

Unverified Answer

Can gastrostomy complications be cured?

"Gastrostomy complications can often be successfully corrected with nonoperative treatment. However, surgery is necessary for a majority of patients. For all patients, successful healing following surgery should be a high priority." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets gastrostomy complications?

"Most complication rates were within 1 year of the procedure. Gastrostomy complications continue to be an area of concern for gastroenterologists in both pediatric and adult patients, even well beyond the 1-year postoperative window." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of treatment?

"Recent findings found that most common side effects of IFN-alpha treatment are of mild or moderate severity, often resolve following cessation of treatment, and rarely result in dosage reduction. The most common side effect is fever. Patients should be informed that their risk of developing these side effects will be increased if they have recently received a blood transfusion in the past." - Anonymous Online Contributor

Unverified Answer

What does treatment usually treat?

"[Surgery is usually performed on an ad hoc basis when needed and rarely for chronic condition(s)</i>. What are the [procedural complications]? <i>[Surgery-related complications]</i> are related to the treatment itself, ie, postoperative infections, postoperative pancreatitis, and so on." - Anonymous Online Contributor

Unverified Answer

What is the latest research for gastrostomy complications?

"Current literature indicates that placement of a gastrostomy remains a simple and safe procedure, with low incidence of complications. This is a highly skilled procedure requiring a high level of skill and experience for the operator to achieve a low rate of complications. Therefore, the gastrostomy is a simple and safe procedure, with low rate of complications." - Anonymous Online Contributor

Unverified Answer

Does gastrostomy complications run in families?

"Because of the family history of gastrojejunostomy complications we have introduced prophylactic measures including an exhaustive gastrointestinal history and ultrasound to evaluate for a "silent" ulcer, or other abnormality. Because no gastrojejunostomies have occurred after implementation of our prophylactic measures, we think this method should be adopted by some other unit." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for gastrostomy complications?

"Patient-related factors, including age, the presence of comorbidities, and BMI, are the most significant predictors of GC complications. Despite this, few clinical trials have targeted GC complications, and the results have not yet been reported. The development of clinical trial protocols specifically addressing GC complications may improve the utilization of GI clinical trials and improve the quality of the patient outcomes." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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