Chronic ConstipationCOMACOMACCNCT06695754
Comparing Manual and Automatic Colonic Massage for Chronic Constipation.
An observational study of Chronic Constipation, run by usMIMA S.L. at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Constipation
- How many people
- 2,312 participants
- Where
- 1 siteSpain
- Study dates
- 18 Dec 2024to 31 Dec 2024
- 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 of any age, gender and etnicity, suffering from chronic constipation
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Systematic Review and Meta-Analysis to Compare the Effectiveness of Manual and Automatic Colonic Massage Interventions in Patients With 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.
Read the 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.
- Conditions
- Chronic Constipation
- Keywords
- manual massage, automatic massage, colonic massage, intermittent colonic exoperistalsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | |
| 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 | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative evaluation of manual vs. automatic colon massage for chronic constipation relief
Quantitative comparison of manual and automatic colon massage efficacy in relieving chronic constipation
Measured: 34 years
Secondary outcomes (4)
Evacuation frequency
Number of bowel movementes per week
Measured: 34 years
Quality of life questionnaire in relation to constipation
Semi-Quantitative score derived from standardized qualitative questionnaires evaluating quality of life in relation to chronic constipation.
Measured: 34 years
Adverse events
Any secondary adverse effect directly derived from the treatment, including Serious Adverse Events (SAE)
Measured: 34 years
Aids to evacuation
Use (total number of days in use or total dose per week) of any aid to facilitate evacuation such as laxatives, enemas, digitation....
Measured: 34 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start18 Dec 2024
- Primary completion23 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic ConstipationStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,312 participants (actual)
Sponsor and investigators
- Lead sponsor
- usMIMA S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Immaculada Herrero-Fresneda, PhD, Study director, usMIMA S.L.Eugenia Delgado, PhD, Principal investigator, usMIMA S.L.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695754
- Sponsor's protocol ID
- MOW_07_2024
- Acronym
- COMACOMACC
- Status last verified
- Jan 2026
- First submitted
- 13 Nov 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Delgado ME, Benet J, Herrero-Fresneda I. Safety and Efficacy of Manual and Automated Abdominal Colonic Massage for Chronic Constipation: A Systematic Review and Meta-Analysis. Clin Transl Gastroenterol. 2026 Jul 1;17(7):e01027. doi: 10.14309/ctg.0000000000001027. Epub 2026 Apr 1.
PubMed 41919979
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Systematic Review and Meta-Analysis to Compare the Effectiveness of Manual and Automatic Colonic Massage Interventions in Patients With Chronic Constipation.
- ClinicalTrials.gov ID
- NCT06695754
- Acronym / sponsor ID
- COMACOMACC / MOW_07_2024
- Conditions
- Chronic Constipation
- Keywords
- manual massage, automatic massage, colonic massage, intermittent colonic exoperistalsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,312 participants (actual)
- Lead sponsor
- usMIMA S.L.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Nov 2024 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
| 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 |
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of any age, gender and etnicity, suffering from chronic constipation
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
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
4 secondary outcomes
Evacuation frequency
Time frame: 34 years
Quality of life questionnaire in relation to constipation
Time frame: 34 years
Adverse events
Time frame: 34 years
Aids to evacuation
Time frame: 34 years
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 21 Jan 2026.
- Derived from this study: PubMed 41919979Delgado ME, Benet J, Herrero-Fresneda I. Safety and Efficacy of Manual and Automated Abdominal Colonic Massage for Chronic Constipation: A Systematic Review and Meta-Analysis. Clin Transl Gastroenterol. 2026 Jul 1;17(7):e01027. doi: 10.14309/ctg.0000000000001027. Epub 2026 Apr 1.
- 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.
Immaculada Herrero-Fresneda, PhD study director
usMIMA S.L.
Eugenia Delgado, PhD principal investigator
usMIMA S.L.
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 Chronic Constipation, run by usMIMA S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. 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?
Quantitative evaluation of manual vs. automatic colon massage for chronic constipation relief (time frame: 34 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06695754, which also lists 1 linked publication.
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 21 Jan 2026.