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Completed

NCT Number: NCT06695754

Comparing Manual and Automatic Colonic Massage for Chronic Constipation.

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Usmima S.L.

Esplugues de Llobregat, Barcelona, 08950, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. Quantitative evaluation of manual vs. automatic colon massage for chronic constipation relief

    Time frame: 34 years

    Quantitative comparison of manual and automatic colon massage efficacy in relieving chronic constipation

Secondary outcomes

  1. Evacuation frequency

    Time frame: 34 years

    Number of bowel movementes per week

  2. Quality of life questionnaire in relation to constipation

    Time frame: 34 years

    Semi-Quantitative score derived from standardized qualitative questionnaires evaluating quality of life in relation to chronic constipation.

  3. Adverse events

    Time frame: 34 years

    Any secondary adverse effect directly derived from the treatment, including Serious Adverse Events (SAE)

  4. Aids to evacuation

    Time frame: 34 years

    Use (total number of days in use or total dose per week) of any aid to facilitate evacuation such as laxatives, enemas, digitation....

Sponsors and collaborators

Lead sponsor

usMIMA S.L.

Industry

Registry information

Official study title

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

Acronym: COMACOMACC

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 19, 2024
Registry last updated
Jan 21, 2026

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.

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