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

NCT ID: NCT05618392

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-09

Study Completion Date

2026-01-01

Brief Summary

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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

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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

Conditions

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Gastrostomy Complications Gastrostomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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single group assignment

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier de Valence

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sandrine Beauchard

Valence, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Mathilde FINOT, MD

Role: CONTACT

+33475818870

Guillaume BUIRET, MD

Role: CONTACT

+33475818870

Facility Contacts

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sandrine Beauchard, MD

Role: primary

+33475818870

Other Identifiers

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RIPH-CHV-11

Identifier Type: -

Identifier Source: org_study_id

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