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

NCT ID: NCT06417424

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-05-31

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.

Detailed 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.

Conditions

Electric Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

experimental group 1

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

Group Type: EXPERIMENTAL

gastrointestinal external stimulation

Intervention Type: 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 2

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

Group Type: EXPERIMENTAL

gastrointestinal external stimulation

Intervention Type: 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 3

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

Group Type: EXPERIMENTAL

gastrointestinal external stimulation

Intervention Type: 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.

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai East Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai easthospital

Shanghai, Pudong New Area, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Lan Zhong, MD

Role: primary

lanzhong@tongji.edu.cn

+86-13162099450

Other Identifiers

DFSC-2023(CR)-077

Identifier Type: -

Identifier Source: org_study_id