Improving bowel cleanliness in elderly patients with constipation using electrical stimulation
A Prospective, Randomized, Double-blind Controlled Clinical Study of Observation the Effect of Gastrointestinal External Stimulation on Intestinal Tract Cleaness in Patients With Senile Constipation
This study tests if using electrical stimulation can help older adults with constipation have cleaner bowels before a colonoscopy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai East Hospital Academic / other |
| Locations | 1 site (Shanghai, Pudong New Area) |
| Trial ID | NCT06417424 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of gastrointestinal external stimulation and transcutaneous electrical acupoint stimulation in enhancing bowel cleanliness among elderly patients with constipation who require colonoscopy. Participants aged 60-80 are randomly assigned to one of four groups: receiving both stimulation methods, one method only, or no stimulation, while all groups are given polyethylene glycol for bowel cleansing. The quality of bowel cleanliness is assessed using the Boston Bowel Preparation Scale (BBPS), with higher scores indicating better cleanliness. The goal is to improve detection rates of intestinal diseases in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are elderly individuals aged 60-80 with a diagnosis of constipation who are scheduled for a colonoscopy.
Not a fit: Patients with acute myocardial infarction, severe heart failure, chronic renal failure, or those on certain medications affecting gastrointestinal motility may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve bowel preparation quality, leading to better detection of intestinal diseases in elderly patients.
How similar studies have performed: While the approach of using electrical stimulation for bowel preparation is innovative, similar studies have shown varying degrees of success in improving bowel cleanliness.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 60-80 years old; 2. Colonoscopy was planned; 3. The diagnosis of constipation was in accordance with Rome Ⅳ criteria. Exclusion Criteria: 1. Acute myocardial infarction (within 6 months), severe heart failure (New York Heart Association class II-V, chronic renal failure (CKD stage II-V), or mental disorder; 2. Colorectal resection; 3. Drugs of aspirin, warfarin, or other anticoagulants, and coagulopathy; 4. Oral administration any drugs that may affect gastrointestinal motility, such as proton pump inhibitors, non-steroidal anti-inflammatory drugs or antibiotics (within 4 weeks), probiotics (within 2 weeks); 5. The following diseases：inflammatory bowel disease, frequent diarrhea, severe gastroparesis, intestinal perforation or obstruction; 6. Participating in other clinical trials.
Where this trial is running
Shanghai, Pudong New Area
- Shanghai easthospital — Shanghai, Pudong New Area, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.