Pain Assessment Following Placement of a Percutaneous Radiologic Gastrostomy and Predictive Factors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gastrostomy Complications, Gastrostomy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Primary outcome measures
- abdominal pain [Time frame: 7 days]
- predictive factors [Time frame: DAY 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Sandrine Beauchard — Valence
Identifiers
NCT: NCT05618392 · RIPH-CHV-11