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

C

Centre Hospitalier de Valence

Status

Enrolling

Conditions

Gastrostomy Complications
Gastrostomy

Study type

Observational

Funder types

Other

Identifiers

NCT05618392
RIPH-CHV-11

Details and patient eligibility

About

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.

Full 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

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

50 participants in 1 patient group

single group assignment
Description:
only one arm. Each patient complete numerical scale questionnaire (0-10)

Trial contacts and locations

1

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Central trial contact

Mathilde FINOT, MD; Guillaume BUIRET, MD

Data sourced from clinicaltrials.gov

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