## Protocol Section
### Identification Module
**NCT ID:** NCT06417424

**Brief Title:** Observe Intestinal Tract Cleaness of Senile Constipation Patients Used Gastrointestinal External Stimulation

**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

#### Organization Study ID Info
**ID:** DFSC-2023(CR)-077
#### Organization
**Class:** OTHER
**Full Name:** Shanghai East Hospital
### Status Module
#### Completion Date
**Date:** 2025-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-12

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-03-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-30
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Shanghai East Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Electric Stimulation

**Keywords:**

- ntestine cleanliness

- senile constipation patients

- Gastrointestinal External Stimula

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 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.

##### Masking Info

**Masking:** TRIPLE

**Masking Description:** The Participants, investigators and outcomes Assessor don't know receiverd which intervention, only care Providers know it.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Device: gastrointestinal external stimulation

**Label:** experimental group 1

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Device: gastrointestinal external stimulation

**Label:** experimental group 2

**Type:** EXPERIMENTAL

#### Arm Group 3

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

**Intervention Names:**

- Device: gastrointestinal external stimulation

**Label:** experimental group 3

**Type:** EXPERIMENTAL

#### Arm Group 4

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

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- experimental group 1

- experimental group 2

- experimental group 3

**Description:** 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.

**Name:** gastrointestinal external stimulation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Boston Bowel Preparation Scale (BBPS)

**Time Frame:** 1 year

**Description:** The positive rate of intestinal diseases including polyps, adenoma, adenocarcinoma, enteritis, inflammatory bowel disease,diverticulum and so on by electronic colonoscopy.

**Measure:** The positive rate of intestinal diseases

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** The adverse reactions included abdominal distension, pain, nausea, vomiting, and fatigue.

**Measure:** Adverse reactions

**Time Frame:** 1 year

**Description:** The Likert scale was used to judge willingness to repeat the same interventions of intestinal cleansing in future electronic colonoscopies.

**Measure:** Willingness to repeat

**Time Frame:** 1 year

**Description:** Collected fresh fecal samples before and 3 days after electrical stimulation, high-throughput sequencing was used to detect intestinal microbiome , analyzed the changes .

**Measure:** Gut microbiome alterations

**Time Frame:** 1 year

**Description:** The serum levels of gastrointestinal hormones including substance P, motilin，ghrelin，growth hormone, neurotensin and vasoactive intestinal peptide were measured before and after intervention.

**Measure:** Gastrointestinal hormone

**Time Frame:** 1 year

### Eligibility Module

**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.

**Maximum Age:** 80 Years

**Minimum Age:** 60 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Email:** lanzhong@tongji.edu.cn

- **Name:** Lan Zhong, MD

- **Phone:** +86-13162099450

- **Role:** CONTACT

**Country:** China

**Facility:** Shanghai easthospital

**State:** Pudong New Area

**Status:** RECRUITING

**Zip:** 200120

### IPD Sharing Statement Module

**IPD Sharing:** YES

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012817

- Term: Signs and Symptoms, Digestive

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M6472

- Name: Constipation

- Relevance: HIGH

- As Found: Constipation

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003248

- Term: Constipation

### Misc Info Module

- Version Holder: 2024-05-31
