Comparing Manual and Automatic Colonic Massage for Chronic Constipation.
NCT ID: NCT06695754
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
300 participants
OBSERVATIONAL
2024-12-23
2024-12-31
Brief Summary
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Detailed Description
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* Computer retrieval of clinical literature on abdominal massage for constipation published between 1990 and December 2024 will be conducted in:
* NCBI PubMed.
* Research Gate.
* Google Scholar.
* Ovid.
* English retrieval terms included: colon, abdominal, constipation, bowel function, transit time, massage, and device.
* A cross-retrieval will be conducted to screen the literature that met the inclusion criteria.
Literature screening and data extraction
* The literature search will be independently performed by two researchers.
* Identified studies will be imported into EndNote×9 and Mendeley for organization.
* Articles will be evaluated based on predefined inclusion and exclusion criteria.
* Duplicates from various databases will be removed.
* Clearly irrelevant articles will be excluded based on their titles and abstracts.
* Full texts of the remaining studies will be thoroughly reviewed, and those that met the criteria will be included.
* The final dataset will be cross-verified.
* Discrepancies will be resolved through discussion or by involving a third researcher with a PhD for arbitration.
* Extracted data included:
* First author's name
* Publication year
* Study type
* Sample size
* Participant gender and age
* Interventions in both experimental and control groups
* Treatment duration and frequency
* Primary and secondary study outcomes
* Quality assessment of the studies
* Study characteristics, along with the study design, description of interventions (type of colon massage applied), and indices of evaluated results, will be organized using an Excel-based data extraction form.
Quality evaluation
* Quality assessment of the literature will be conducted using the "risk of bias" tool recommended by the Cochrane Handbook for Systematic Reviews (Rob2.0 and Robins-E). These tools evaluate various bias domains, including randomization, deviations from intended interventions, missing data, outcome measurement, and selective reporting. Each domain will be rated as having a high, unclear, or low risk of bias.
* Disagreements between the two researchers regarding the literature's conclusions will be resolved through discussion or by a third researcher.
Conditions
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Keywords
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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Manual massage <90% over colon
Patients received a manual massage or treatment that reachs the ascending and descending colon for less than 90% of the total time of the treatment duration
No interventions assigned to this group
Manual massage >90% over colon
Patients received a manual massage or treatment that reachs the ascending and descending colon for 90% or more of the total time of treatment duration
No interventions assigned to this group
Automatic massage
Patients received a massage or treatment delivered with a medical device, that reachs the ascending and descending colon for 90% or more of the total time of treatment duration
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Clinical studies using abdominal/colon massage to treat constipation.
* Articles published between 1990 and till the day of literature search with original work (experimental and quasi-experimental ) or dealing with the application of colon massage to gastrointestinal function.
* Study subjects:
* Patients with constipation.
* Individuals of any gender, age and ethnicity.
* Interventions:
\- Manual or automatic colon massage treatment for constipation.
* Outcomes (including at least one of the following):
* Evacuation frequency.
* Quality of life parameters.
* Symptoms of constipation.
* Use of laxatives or enemas.
* Adverse events.
Exclusion Criteria
* Studies where the treatment was non-colon specific.
* Studies involving invasive treatments.
* Other treatments intended to treat constipation such as surgical interventions, acupuncture, acupoint application, and others considered medicinal alternative therapies.
* Documents written in languages other than in English, German, Spanish, as well as other European languages, including Italian, French, and Portuguese.
* Incorrect or incomplete case data.
ALL
No
Sponsors
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usMIMA S.L.
INDUSTRY
Responsible Party
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Principal Investigators
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Immaculada Herrero-Fresneda, PhD
Role: STUDY_DIRECTOR
usMIMA S.L.
Eugenia Delgado, PhD
Role: PRINCIPAL_INVESTIGATOR
usMIMA S.L.
Locations
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Usmima S.L.
Esplugues de Llobregat, Barcelona, Spain
Countries
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Central Contacts
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Immaculada Herrero-Fresneda (Chief Scientific Officer), PhD
Role: CONTACT
Phone: +34 935106653
Email: [email protected]
Facility Contacts
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CSO
Role: primary
Medical Writer
Role: backup
Immaculada Herrero-Fresneda, PhD
Role: backup
Eugenia Delgado, PhD
Role: backup
Other Identifiers
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MOW_07_2024
Identifier Type: -
Identifier Source: org_study_id