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CO2 vs Air Insufflation in Children Undergoing PEG

NCT04714021 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-01-19

No results posted yet for this study

Summary

Ap¬plications of CO2 insufflation for endoscopic procedures have been reported for the performance of routine colonoscopy, small bowel endoscopy, endoscopic retro¬grade cholangiopancreatography (ERCP) and endoscopic submucosal dissection in the upper and lower gastrointestinal tracts. These studies showed that CO2 insufflation reduces the post-procedural abdominal distension and pain without CO2 retention and adverse events. However, there has been no report on the safety and efficacy of CO2 insufflation in PEG procedures in adults or in children. In the present study, we would like to evaluate by randomized controlled trial: the safety of the CO2 insufflation during PEG and the inhibi¬tory effects of CO2 insufflation on bowel distension after PEG.

Conditions

  • Gastrostomy

Interventions

OTHER

CO2

to insufflate CO2 into the stomach instead of air during the PEG

OTHER

air

to insufflate air into the stomach instead of CO2 during the PEG

Sponsors & Collaborators

  • European Society of Pediatric Gastroenterology, Hepatology and Nutrition

    collaborator OTHER

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Matjaz Homan, PhD · Children's Hospital in Ljubljana

  • Mike Thomson, PhD · Sheffield Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-07
Primary Completion
2023-01-07
Completion
2023-01-07

Countries

  • Belgium
  • Croatia
  • Italy
  • Slovenia
  • Switzerland
  • United Arab Emirates
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04714021 on ClinicalTrials.gov