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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05618392

Acronym

DOULEURGPR

Enrollment

Registered

2022-11-16

Start date

2022-12-09

Completion date

2026-09-01

Last updated

2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrostomy, Gastrostomy Complications

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

France

Contacts

CONTACTMathilde FINOT, MD

mfinot@ch-valence.fr+33475818870

CONTACTGuillaume BUIRET, MD

gbuiret@ch-valence.fr+33475818870

Outcome results