Pain Assessment Following Placement of a Percutaneous Radiologic Gastrostomy and Predictive Factors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier de Valence
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Needing a radiologic gastrostomy under local anesthesia
Age ≥ 18 years old
Read, write and understand the French language
Disqualifiers
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 population
patients needing a Percutaneous radiologic Gastrostomy under local anesthesia
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 1 trial groupGroup A: single group assignment
Trial outcomes
Primary outcomes
1
abdominal pain
numerical scale 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable."
Time frame
7 days2
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)
Time frame
DAY 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov