Intestinal Dysmotility: Minute Rythm

Intestinal Dysmotility in Patients With Functional Digestive Symptoms: Significance of Minute Rythm

Introduction: Intestinal manometry may detect phasic pressure patterns that suggest small bowel obstruction. The most common is the "clustered contractions pattern", characterized by repetitive short spouts of intestinal contractions in the postprandial period. When encountered in patients with chronic unexplained digestive symptoms, an exhaustive radiological evaluation of the gut should be performed to exclude partial mechanical obstruction. If no luminal compromise is identified by the imaging studies, an underlying neuropathic disorder of the bowel may be the probable diagnosis. The objective of this study was to determine the clinical significance of this pattern in patients evaluated for a possible intestinal motility disorder. Study design: Retrospective analysis of the of patients with minute rhythm pattern detected in intestinal manometric recordings performed between 2010 and 2018 at the Vall d'Hebron Digestive Function Unit in consecutive patients referred for evaluation of intestinal motility due to severe, chronic digestive symptoms and suspected dysmotility. The manometric recordings that had been informed of minute rhythm pattern, will be retrieved to confirm the original report. The clinical records of these patients will be reviewed to obtain: a) demographic data, b) digestive symptoms at the time of evaluation, c) history of abdomino-pelvic surgeries or radiotherapy prior to manometry, d) diagnosis of systemic disorders, and e) presence of esophageal, gastric or colonic dysmotility. Results from radiological and other investigations will be also revised, as well as therapeutic decisions and clinical outcome. Particularly, whether abdominal imaging studies (simple abdominal X-ray or abdominal CT scans) were performed within 7 days of the manometric study, and whether these studies showed signs of fecal retention (presence of solid stools in the right colon) or not.

Study Overview

• Status: Completed
• Conditions: Motility Disorder of Small Intestine (Disorder)

• Study Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with minute rhythm pattern detected in intestinal manometric recordings performed between 2010 and 2018 at the Vall d'Hebron Digestive Function Unit in consecutive patients referred for evaluation of intestinal motility due to severe, chronic digestive symptoms and suspected dysmotility.

Description

Inclusion criteria:

- Patients with minute rhythm pattern by intestinal manometry, defined as short clusters of 3-5 contractions repeating every 1-3 min and occurring over a ≥ 20-cm intestinal segment during a ≥ 30-min period in postprandial conditions.

Exclusion criteria:

• Patients with an incomplete (< 2 hour) postprandial recording.
• Patients with minute rhythm detected exclusively in fasting conditions or lasting less than 30 min in postprandial conditions.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fecal retention	Presence of solid stools in the right colon in abdominal imaging studies (simple abdominal X-ray or abdominal CT scans) performed within 7 days of the manometric study	7 days

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborators: Instituto de Salud Carlos III

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 30, 2021
• Primary Completion (ACTUAL): January 1, 2022
• Study Completion (ACTUAL): January 10, 2022

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: February 7, 2022
• First Posted (ACTUAL): February 8, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PR(AG)56/2018D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No