RecruitingNot ApplicableNCT06417424

Observe Intestinal Tract Cleaness of Senile Constipation Patients Used Gastrointestinal External 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


Sponsor

Shanghai East Hospital

Enrollment

60 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, randomized, double-blind controlled trial. Elderly patients with constipation requiring colonoscopy were randomly divided into four groups: 1. Received both gastrointestinal external stimulation and transcutaneouselectrical acupoint stimulation; 2. Received gastrointestinal external stimulation singly; 3. Received transcutaneouselectrical acupoint stimulation singly; 4. No stimulation was given. All groups received oral administration of polyethylene glycol for intestinal cleansing. Boston Bowel Preparation Scale (BBPS) score was used to assess the quality of intestinal cleanliness , with a total score of 9, and higher scores indicating better intestinal cleanliness, and BBPS≥6 was defined effective.


Eligibility

Min Age: 60 YearsMax Age: 80 Years

Inclusion Criteria3

  • Age 60-80 years old;
  • Colonoscopy was planned;
  • The diagnosis of constipation was in accordance with Rome Ⅳ criteria.

Exclusion Criteria6

  • 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;
  • Colorectal resection;
  • Drugs of aspirin, warfarin, or other anticoagulants, and coagulopathy;
  • 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);
  • The following diseases:inflammatory bowel disease, frequent diarrhea, severe gastroparesis, intestinal perforation or obstruction;
  • Participating in other clinical trials.

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Interventions

DEVICEgastrointestinal external stimulation

We used the device Gastrointestinal multifunctional therapeutic instrument. The positive pole was placed 1 to 2cm above the umbilicus, and the negative pole was placed 4 to 10 cm to the right of the midpoint between the xiphoid process and the umbilicus.


Locations(1)

Shanghai easthospital

Shanghai, Pudong New Area, China

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NCT06417424


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