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A Randomized Controlled Study on the Effects of the Gastrointestinal Vibration Capsule System on Postoperative Ileus and Oral Nutritional Tolerance in Major Gastrointestinal Surgery

A Randomized Controlled Study on the Effects of the Gastrointestinal Vibration Capsule System on Postoperative Ileus and Oral Nutritional Tolerance in Major Gastrointestinal Surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093676
Enrollment
Unknown
Registered
2024-12-10
Start date
2024-12-20
Completion date
Unknown
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative ileus

Interventions

Vibrating capsule group:Vibrating capsule
Placebo capsule group:Placebo capsule (sham capsule)

Sponsors

The Second Affiliated Hospital of Kunming Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for elective laparoscopic radical distal gastrectomy or radical right hemicolectomy with one-stage anastomosis. 2. Age of 18-85 years old. 3. ASA physical status I-III patients. 4. First gastrointestinal surgery or major abdominal surgery. 5. Informed consent was obtained to participate in the study.

Exclusion criteria

Exclusion criteria: 1. Patients requiring combined resection of other abdominal organs, or in whom the surgical approach is changed intraoperatively (conversion from laparoscopic to open surgery, gastrointestinal stoma creation, or non-resective gastrointestinal bypass procedures). 2. Patients with known allergy to high-molecular-weight materials, or those with implanted pacemakers (e.g., implantable cardioverter-defibrillator, ICD) or any other electronic, magnetic, or mechanically controlled implanted devices in the body. 3. Patients with abdominal aortic aneurysm, gastrointestinal vascular lesions, severe bleeding tendency, or residual active inflammatory bowel disease. 4. Patients with severe underlying diseases of the heart, brain, lungs, liver, or kidneys. 5. Patients with active diseases that affect gastrointestinal transit/motility (e.g., myasthenia gravis or slow-transit constipation syndrome). 6. Patients who have participated in or are currently participating in other clinical trials/studies.

Design outcomes

Primary

MeasureTime frame
First postoperative defecation and oral diet tolerance time(GI-2);

Secondary

MeasureTime frame
Time to first flatus;Time to first defecation;Time to tolerance of semi-liquid or solid diet;Success rate of oral nutritional support;Postoperative ileus;Prolonged postoperative ileus;Recurrent postoperative ileus;Nasogastric tube reinsertion;Postoperative Complications;Length of postoperative hospital stay;Readmission within 30 days after discharge;

Countries

China

Contacts

Public ContactSun Dali

The Second Affiliated Hospital of Kunming Medical University

destingky@163.com+86 135 7704 7806

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026