The Effect of Transcutaneous Electrical Acustimulation on Small Bowel Preparation for Capsule Endoscopy

NCT ID: NCT06099392

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-12-01

Brief Summary

Transcutaneous elctroacupuncture(TEA) at ST36 can improve gastrointestinal motility. Therefore,the investigators hypothesized that if TEA is applied to the preparation of small bowel capsule endoscopy, the small bowel peristalsis of patients can be regulated by electrical stimulation at (ST36). On the one hand, it can be used in combination with compound polyethylene glycol electrolyte powder, which is conducive to the discharge of small bowel contents and improve the imaging quality. On the other hand, it can improve the diagnostic rate by adjusting the intestinal transit time, And the completion rate of the examination can be improved by accelerating the gastric emptying time of capsule endoscopy.

Therefore, in order to explore the effect of TEA stimulation at ST36 combined with polyethylene glycol powder on preparation for small bowel capsule endoscopy, the investigators designed this study.

Conditions

Quality of Small Bowel Preparation

Study Design

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

Study Groups

TEA group

TEA at ST36 (Zusanli) combined with 2L Polyethylene Glycol Electrolytes Powder for bowel preparation

Group Type: EXPERIMENTAL

digital stimulators (SNM-FDC01, Ningbo MaidaMedical Device, Inc, Ningbo, China)

Intervention Type: DEVICE

TEA at Zusanli(ST 36) 45 min when drinking Polyethylene Glycol Electrolytes Powder

Sham-TEA group

2L Polyethylene Glycol Electrolytes Powder for bowel preparation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

digital stimulators (SNM-FDC01, Ningbo MaidaMedical Device, Inc, Ningbo, China)

TEA at Zusanli(ST 36) 45 min when drinking Polyethylene Glycol Electrolytes Powder

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Agree to sign an informed consent form; Aged 18 to 75 years old Plan to undergo small bowel capsule endoscopy;

Exclusion Criteria

Clinical diagnosis of gastrointestinal stricture, bowel obstruction, gastrointestinal fistula, intestinal resection; Clinical diagnosis of dysphagia; Those who require fasting or parenteral nutrition support treatment; Individuals with gastrointestinal motility disorders; Oral administration of gastrointestinal motility drugs within 1 week; Implanting medical electronic devices; Those who are allergic to compound polyethylene glycol electrolyte powder and dimethicone oil and cannot tolerate oral laxatives for intestinal preparation; Skin diseases that affect electrode fixation; Pregnant, preparing to conceive, or breastfeeding patients; Familiar with acupuncture and moxibustion treatment, acupoint selection or meridians; Researchers believe that it is not suitable for participants.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

RenJi Hospital

OTHER

Sponsor Role: collaborator

Shanghai Changzheng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wei-Fen Xie

Head of gastroenterology, Shanghai Changzheng Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Wei-Fen Xie, MD. PhD

Role: CONTACT

weifenxie@medmail.com.cn

(86) 21 81886824.

Other Identifiers

CZXH202301

Identifier Type: -

Identifier Source: org_study_id