Complications Associated With Primary Placement of Gastrostomy for Feeding

NCT05173935 | Completed

• 1 other identifier: 16-010077
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare pain, complications, and quality of life after gastrostomy tube is placed by either percutaneous endoscopic gastrostomy (PEG) or radiologically-inserted gastrostomy (RIG) method.

Conditions

Gastrostomy Tube

Keywords

complication; quality of life; pain

Outcome Measures

Primary Outcomes (6)

• Change in pain with gastrostomy-tube placement, comparing RIG with PEG

  Trajectory of the average pain score over time (question 3, Cleeland Brief Pain Inventory), which rates average pain in the past 24 hours, with 0 being no pain and 10 being pain as bad as can be imagined

  Before the procedure, within 24 hours after procedure, at 48-96 hours after procedure, and at 6 weeks after procedure

• Major and minor complications with gastrostomy-tube placement, comparing RIG with PEG

  Assessment of the following major complications after procedure: Peritonitis, Abscess, Major bleeding requiring intervention and/or transfusion, Bowel perforation, Death; Assessment of the following minor complications after procedure: Minor bleeding, not requiring transfusion, Tube occluded, Tube malpositioned/fell out,Tube damaged, Skin erosion, Site redness, Site nodules/induration, Site exudate

  Within 24 hours after procedure

• Major and minor complications with gastrostomy-tube placement, comparing RIG with PEG

  Assessment of the following major complications after procedure: Peritonitis, Abscess, Major bleeding requiring intervention and/or transfusion, Bowel perforation, Death; Assessment of the following minor complications after procedure: Minor bleeding, not requiring transfusion, Tube occluded, Tube malpositioned/fell out,Tube damaged, Skin erosion, Site redness, Site nodules/induration, Site exudate

  At 6 weeks after procedure

• Minor complications with gastrostomy-tube placement, comparing RIG with PEG

  Assessment of the following complications after procedure: Tube occluded, Tube malpositioned/fell out, Tube damaged, Skin erosion, Site redness, Site nodules/induration, Site exudate

  At 3 months, if tube still in place

• Minor complications with gastrostomy-tube placement, comparing RIG with PEG

  Assessment of the following complications after procedure: Tube occluded, Tube malpositioned/fell out, Tube damaged, Skin erosion, Site redness, Site nodules/induration, Site exudate

  At 6 months, if tube still in place

• Minor complications with gastrostomy-tube placement, comparing RIG with PEG

  Assessment of the following complications after procedure: Tube occluded, Tube malpositioned/fell out, Tube damaged, Skin erosion, Site redness, Site nodules/induration, Site exudate

  At 9 months, if tube still in place

Secondary Outcomes (4)

• Costs associated with gastrostomy tube placement, comparing RIG with PEG

  Immediately after procedure completion

• Anesthesia type associated with gastrostomy tube placement, comparing RIG with PEG

  Immediately after procedure completion

• Patient quality of life associated with gastrostomy tube placement, comparing RIG with PEG, before and after the procedure

  Before the procedure

• Patient quality of life associated with gastrostomy tube placement, comparing RIG with PEG, before and after the procedure

  At 6 weeks after procedure

Study Arms (2)

PEG Group

ACTIVE COMPARATOR

Subjects will gastrostomy tube placement via percutaneous endoscopic gastrostomy (PEG) method.

Procedure: Percutaneous endoscopic gastrostomy

RIG Group

ACTIVE COMPARATOR

Subjects will have the placement of a gastrostomy tube via radiologically-inserted gastrostomy (RIG) method.

Procedure: Radiologically-inserted gastrostomy

Interventions

Percutaneous endoscopic gastrostomy PROCEDURE

Gastrostomy tube placement using an endoscopic camera inserted via the mouth into the stomach to place the tube.

PEG Group

Radiologically-inserted gastrostomy PROCEDURE

Gastrostomy tube placement using a temporary nasogastric tube placed from nose to stomach and fluoroscopy (x-rays).

RIG Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years
• Cannot maintain adequate nutrition by mouth

You may not qualify if:

• Venting-only gastrostomy
• Patients with Amyotrophic Lateral Sclerosis (ALS)
• Coagulopathy with uncorrectable International Normalized Ratio (INR) greater than 1.5 or inability to hold anticoagulation
• Structural abnormality that would prevent one or both techniques
• Known severe esophageal stricture
• Obstructing malignancy in oropharynx or esophagus that prohibits pull-through technique
• Neoplastic, inflammatory, or infiltrative disease of abdominal wall or gastric wall
• Known hepatomegaly
• Abdominal wall mesh
• Enteric functional abnormality
• Small bowel or colonic obstruction
• Gastric or small bowel dysmotility
• Active abdominal infection/peritonitis/enterocutaneous fistula
• Ascites
• Ventriculoperitoneal shunt

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melissa Neisen, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are randomized to receive either RIG or PEG. Investigator and Outcomes Assessors are masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 30, 2021
• Study Start: December 8, 2017
• Primary Completion: July 29, 2021
• Study Completion: July 29, 2021
• Last Updated: January 11, 2023

Record last verified: 2023-01

Locations

US (1)