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Completed

NCT Number: NCT05230121

Intestinal Dysmotility: 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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. fecal retention

    Time frame: 7 days

    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

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2022
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.