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

NCT06417424 | Recruiting

• 1 other identifier: DFSC-2023(CR)-077
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Electric Stimulation

Keywords

ntestine cleanliness; senile constipation patients; Gastrointestinal External Stimula

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Adverse reactions

  1 year

• Willingness to repeat

  1 year

• Gut microbiome alterations

  1 year

• Gastrointestinal hormone

  1 year

Study Arms (4)

experimental group 1

EXPERIMENTAL

Received both gastrointestinal external stimulation and transcutaneouselectrical acupoint stimulation for 3 days, and then oral administration of polyethylene glycol for intestinal cleansing.

Device: gastrointestinal external stimulation

experimental group 2

EXPERIMENTAL

Received gastrointestinal external stimulation singly, and then oral administration of polyethylene glycol for intestinal cleansing.

Device: gastrointestinal external stimulation

experimental group 3

EXPERIMENTAL

Received transcutaneouselectrical acupoint stimulation singly, and then oral administration of polyethylene glycol for intestinal cleansing.

Device: gastrointestinal external stimulation

Control

NO INTERVENTION

No stimulation was given. Oral administration of polyethylene glycol for intestinal cleansing.

Interventions

gastrointestinal external stimulation DEVICE

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.

experimental group 1; experimental group 2; experimental group 3

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai easthospital

Shanghai, Pudong New Area, 200120, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Participants, investigators and outcomes Assessor don't know receiverd which intervention, only care Providers know it.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: May 16, 2024
• Study Start: February 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: May 31, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)