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

Tongji University

Status: Enrolling

Conditions: Electric Stimulation

Treatments: Device: gastrointestinal external stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06417424

DFSC-2023(CR)-077

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 4 patient groups

experimental group 1

Experimental group

Description:

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

Treatment:

Device: gastrointestinal external stimulation

experimental group 2

Experimental group

Description:

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

Treatment:

Device: gastrointestinal external stimulation

experimental group 3

Experimental group

Description:

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

Treatment:

Device: gastrointestinal external stimulation

Control

No Intervention group

Description:

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