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

NCT05618392 | Recruiting

• 1 other identifier: RIPH-CHV-11
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrostomy Complications; Gastrostomy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

single group assignment

only one arm. Each patient complete numerical scale questionnaire (0-10)

Eligibility Criteria

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

Study Population

patients needing a Percutaneous radiologic Gastrostomy under local anesthesia

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Valence: lead

Study Sites (1)

Sandrine Beauchard

Valence, 26400, France

RECRUITING

Central Study Contacts

Mathilde FINOT, MD

CONTACT

+33475818870; mfinot@ch-valence.fr

Guillaume BUIRET, MD

CONTACT

+33475818870; gbuiret@ch-valence.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: November 16, 2022
• Study Start: December 9, 2022
• Primary Completion: December 9, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

FR (1)