Clinical trial NCT06695754: Comparing Manual and Automatic Colonic Massage for Chronic Constipation.
Official title: A Systematic Review and Meta-Analysis to Compare the Effectiveness of Manual and Automatic Colonic Massage Interventions in Patients with Chronic Constipation.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Constipation
Keywords: manual massage
automatic massage
colonic massage
intermittent colonic exoperistalsis
Lead sponsor: usMIMA S.L.
Sponsor class: INDUSTRY
First posted: 2024-11-19
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of any age, gender and etnicity, suffering from chronic constipation

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.

Eligibility 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.

Primary outcomes:
measure: Quantitative evaluation of manual vs. automatic colon massage for chronic constipation relief
timeFrame: 34 years
Secondary outcomes:
measure: Evacuation frequency
timeFrame: 34 years
measure: Quality of life questionnaire in relation to constipation
timeFrame: 34 years
measure: Adverse events
timeFrame: 34 years
measure: Aids to evacuation
timeFrame: 34 years
Other outcomes:
Locations:
city: Esplugues de Llobregat
country: Spain
facility: Usmima S.L.
state: Barcelona
Study officials:
affiliation: usMIMA S.L.
name: Immaculada Herrero-Fresneda, PhD
role: STUDY_DIRECTOR
affiliation: usMIMA S.L.
name: Eugenia Delgado, PhD
role: PRINCIPAL_INVESTIGATOR
References: