Pain Assessment Following Placement of a Percutaneous Radiologic Gastrostomy and Predictive Factors

Recruiting

• Conditions: Gastrostomy; Gastrostomy Complications

• Registration Number: NCT05618392
• Lead Sponsor: Centre Hospitalier de Valence

Brief Summary

A 12 months mono-center, descriptive study, to evaluate pain and predictive factors Following placement of percutaneous Radiologic gastrostomy (PRG).

The primary objective is to evaluate the abdominal pain associated with percutaneous radiologic gastrostomy (PRG) placement.

Detailed Description

PRG is a pathway first of all enteral nutrition that has several advantages: local anesthesia, possible in case of esophageal stenosis, Rates of successful tube placement higher for radiologic gastrostomy than for percutaneous endoscopic Gastrostomy (PEG).

Abdominal pain following percutaneous radiologic gastrostomy (PRG) placement is a recognized complication. However, the prevalence and degree of severity of pain are poorly characterized. This pain often requires antalgic treatment.

The primary objective is to evaluate the abdominal pain from Baseline until 7 days after radiologic gastrostomy (PRG) placement.

The secondary objective is to evaluate predictive factors

Study Timeline

• Study First Submitted: 2022-06-03
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-16
• Study Start: 2022-12-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-11
• Primary Completion: 2025-12-09
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Needing a radiologic gastrostomy under local anesthesia
• Age ≥ 18 years old
• Read, write and understand the French language

Exclusion Criteria

• Patient under guardianship, deprived of liberty, safeguard of justice
• Patient presenting a serious psychiatric pathology that does not allow compliance with the completion of the questionnaires (at the discretion of the investigator)
• Refusal to participate in research

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
abdominal pain	7 days	numerical scale 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
predictive factors	DAY 1	determine predictive factors of pain suspected in advance: * Fasting anterior stomach wall depth estimated during the ultrasound survey(mm); * Gastric topography determined under X-ray (subcostal / partially retrohepatic); * Topography of the anchors: large tuberosity / antrum; * Distance of anchors from each other (mm); * Depth of the anchors (mm); * Skin depression of anchors: (with depression, without depression); * Intraparietal length of the gastrostomy tube (mm)

Trial Locations

Locations (1)

Sandrine Beauchard; 🇫🇷 Valence, France