High Resolution Colonic Manometry in Relation to 3D-Transit Times in Healthy Controls.

Janne Ladefoged Fassov20 enrolled

Overview

Background: Within recent years, new methods for detailed assessment of gastrointestinal (GI) motility have been developed. Hence, the electromagnetic 3D-Transit system is a safe, non-invasive method for detailed description of GI motility. The system tracks the exact position of an ingested electromagnetic capsule through the entire GI tract and provides detailed information on both regional transit- and contraction patterns. High Resolution Colonic Manometry (HRCM) allows extremely detailed description of contraction patterns in the colon. The HRCM is however an invasive method, as the catheter is placed during colonoscopy. Before widespread use of capsule-based techniques (3D-Transit or others), the system needs to be validated by another method. Study Objectives: The purpose of this study is to investigate weather pressure changes measured by HRCM correlate with passage patterns recorded by 3D-Transit. This has been assumed so far, but has never been further investigated. Hypothesis: Movement of the electromagnetic 3D-Transit capsule within the colon correspond well with pressure changes determined with HRCM. Materials and methods: HRCM and 3D-transit will be performed simultaneously in 20 healthy participants. A colonoscopy is performed to install the HRCM catheter and place two 3D-Transit capsules within the colon. For 24 hours, the participants lie in a bed in the research lab while pressure changes from the HRCM catheter are recorded and the 3D-Transit capsules are followed through the gastrointestinal system. Perspectives: If data from the 3D-Transit technique correlate well with HRCM, the method provide a non-invasive alternative allowing detailed assessment of colonic motility.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Healthy Colonic Motility

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 18 and 70 * Normal gastrointestinal function * Psychologically able to give an informed content. Exclusion Criteria: * Known gastrointestinal disease * Intake of medication with known effects on the movement patterns in the gastrointestinal system. * Pregnancy and lactation * Unable to follow the scheduled program in the trial due to mental illness or instability.

Outcomes

Primary Outcomes

Correlation between pressure changes and passage patterns

Do the high amplitude propagating contraction patterns accessed with High Resolution Colonic Manometry occur simultaneously with the long fast antegrade movements determined with the 3D-Transit system.

Time frame: 24 hours measurement

Secondary Outcomes

Distance of capsule movement and pressure changes

How do the length of a pressure change measured by High Resolution Colonic Manometry correlate with the distance covered in long fast antegrade movements determined with the 3D-Transit system (cm).