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Comparing Manual and Automatic Colonic Massage for Chronic Constipation.

A Systematic Review and Meta-Analysis to Compare the Effectiveness of Manual and Automatic Colonic Massage Interventions in Patients With Chronic Constipation.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06695754
Acronym
COMACOMACC
Enrollment
2312
Registered
2024-11-19
Start date
2024-12-18
Completion date
2024-12-31
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Constipation

Keywords

manual massage, automatic massage, colonic massage, intermittent colonic exoperistalsis

Brief summary

The aim of this study is to do a systematic review and metanalysis of the scientific literature to compare the effectiveness of the manual vs the automatic colonic massage intervention in patients with chronic constipation.

Detailed description

Retrieval Strategy * 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.

Interventions

None listed

Sponsors

usMIMA S.L.
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Literature Inclusion Criteria: * Study type: * 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. Literature

Exclusion criteria

* No abstract available, reviews, conference abstracts, dissertations, registration documents, clinical experience summary analysis, animal experiments, etc. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Quantitative evaluation of manual vs. automatic colon massage for chronic constipation relief34 yearsQuantitative comparison of manual and automatic colon massage efficacy in relieving chronic constipation

Secondary

MeasureTime frameDescription
Evacuation frequency34 yearsNumber of bowel movementes per week
Quality of life questionnaire in relation to constipation34 yearsSemi-Quantitative score derived from standardized qualitative questionnaires evaluating quality of life in relation to chronic constipation.
Adverse events34 yearsAny secondary adverse effect directly derived from the treatment, including Serious Adverse Events (SAE)
Aids to evacuation34 yearsUse (total number of days in use or total dose per week) of any aid to facilitate evacuation such as laxatives, enemas, digitation....

Countries

Spain

Contacts

STUDY_DIRECTORImmaculada Herrero-Fresneda, PhD

usMIMA S.L.

PRINCIPAL_INVESTIGATOREugenia Delgado, PhD

usMIMA S.L.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026