Motility Disorder of Small Intestine (Disorder)NCT05230121
Intestinal Dysmotility: Minute Rythm
An observational study of Motility Disorder of Small Intestine (Disorder), run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Motility Disorder of Small Intestine (Disorder)
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 30 Nov 2021to 10 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start30 Nov 2021
- Primary completion1 Jan 2022
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motility Disorder of Small Intestine (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230121
- Sponsor's protocol ID
- PR(AG)56/2018D
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Dysmotility in Patients With Functional Digestive Symptoms: Significance of Minute Rythm
- ClinicalTrials.gov ID
- NCT05230121
- Acronym / sponsor ID
- PR(AG)56/2018D
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motility Disorder of Small Intestine (Disorder), run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fecal retention (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.