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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastrostomy; Gastrostomy Complications

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 Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Mathilde FINOT, MD; Phone Number: +33475818870; Email: mfinot@ch-valence.fr
• Study Contact Backup: Name: Guillaume BUIRET, MD; Phone Number: +33475818870; Email: gbuiret@ch-valence.fr

Study Locations

• France
  • Valence, France, 26400
    • Recruiting
    • Sandrine Beauchard
    • Contact: sandrine Beauchard, MD; Phone Number: +33475818870; Email: sbeauchard@ch-valence.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients needing a Percutaneous radiologic Gastrostomy under local anesthesia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
single group assignment; only one arm. Each patient complete numerical scale questionnaire (0-10)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
abdominal pain	numerical scale 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."	7 days
predictive factors	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)	DAY 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Valence

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2022
• Primary Completion (Estimated): December 9, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: June 3, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 15, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 00005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No