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

Gastrostomy Clinical Trial

— DOULEURGPR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05618392
• Other study ID #: 00005
• Status: Recruiting
• Start date: December 9, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: December 2023
• Source: Centre Hospitalier de Valence
• Contact: Mathilde FINOT, MD
• Phone: +33475818870
• Email: mfinot[@]ch-valence.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 1, 2026
• Est. primary completion date: December 9, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrostomy
• Gastrostomy Complications

Locations

Country	Name	City	State
France	Sandrine Beauchard	Valence

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier de Valence

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	abdominal pain	numerical scale 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."	7 days
Primary	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