Observe Intestinal Tract Cleaness of Senile Constipation Patients Used Gastrointestinal External Stimulation

Electric Stimulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06417424
• Other study ID #: DFSC-2023(CR)-077
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Shanghai East Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The early detection of intestinal lesions is extremely important, and the quality of intestine cleanliness is an important factor for the quality of colonoscopy. The elderly are at high risk of intestinal diseases. However, surveys have found that the overall quality of bowel cleanliness in elderly patients undergoing colonoscopy is poor, which affects the detection rate of colon lesions. This is a prospective, randomized, double-blind, controlled clinical trial to observe whether combined gastrointestinal surface stimulation and transcutaneous electrical acupoint stimulation can improve the quality of bowel cleansing and increase the detection rate of intestinal diseases. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 60-80 years old;

2. Colonoscopy was planned;

3. The diagnosis of constipation was in accordance with Rome ? 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.

Related Conditions & MeSH terms

• Constipation
• Electric Stimulation

Intervention

Device:
• gastrointestinal 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

Country	Name	City	State
China	Shanghai easthospital	Shanghai	Pudong New Area

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Bowel Preparation Scale (BBPS)	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.	1 year
Primary	The positive rate of intestinal diseases	The positive rate of intestinal diseases including polyps, adenoma, adenocarcinoma, enteritis, inflammatory bowel disease,diverticulum and so on by electronic colonoscopy.	1 year
Secondary	Adverse reactions	The adverse reactions included abdominal distension, pain, nausea, vomiting, and fatigue.	1 year
Secondary	Willingness to repeat	The Likert scale was used to judge willingness to repeat the same interventions of intestinal cleansing in future electronic colonoscopies.	1 year
Secondary	Gut microbiome alterations	Collected fresh fecal samples before and 3 days after electrical stimulation, high-throughput sequencing was used to detect intestinal microbiome , analyzed the changes .	1 year
Secondary	Gastrointestinal hormone	The serum levels of gastrointestinal hormones including substance P, motilin,ghrelin,growth hormone, neurotensin and vasoactive intestinal peptide were measured before and after intervention.	1 year