Comparing Manual and Automatic Colonic Massage for Chronic Constipation. (COMACOMACC)

usMIMA

Status: Completed

Conditions: Chronic Constipation

Study type: Observational

Funder types: Industry

Identifiers

NCT06695754

MOW_07_2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,312 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

2,312 participants in 3 patient groups

Manual massage <90% over colon

Description:

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

Description:

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

Description:

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