Effects of cardiopulmonary bypass duration on gastrointestinal complications
Incidence, Risk Factors, and Outcomes of Gastrointestinal Complications in Patients Undergoing Heart Valve Replacement With Cardiopulmonary Bypass
This study looks at whether longer heart surgery times on a heart-lung machine lead to more stomach problems after surgery for patients getting heart valve replacements.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1600 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hepatopancreatobiliary Surgery Institute of Gansu Province Academic / other |
| Locations | 1 site (Lanzhou, Gansu) |
| Trial ID | NCT06697405 on ClinicalTrials.gov |
What this trial studies
This observational study examines how the length of cardiopulmonary bypass (CPB) during heart valve replacement surgery affects the occurrence of gastrointestinal complications (GICs). Patients will be categorized based on their CPB duration into normal (less than 120 minutes) and prolonged (120 minutes or more) groups. The study aims to identify whether longer CPB times correlate with a higher risk of GICs and to assess the recovery outcomes for those who experience these complications post-surgery. Established diagnostic criteria will be used to evaluate GICs, including clinical symptoms and necessary imaging. The ultimate goal is to enhance surgical outcomes by reducing the incidence and severity of postoperative GICs.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 who are scheduled for heart valve replacement surgery involving cardiopulmonary bypass.
Not a fit: Patients with a history of significant gastrointestinal issues or recent major gastrointestinal surgeries are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced gastrointestinal complications for patients undergoing heart valve replacement.
How similar studies have performed: While the relationship between CPB duration and GICs has been explored in other studies, this specific investigation into the correlation is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing heart valve replacement with CPB * Age ≥ 18 years and ≤ 75 years Exclusion Criteria: * Have received major gastrointestinal surgery within 5 years. * History of severe infection (e.g., pneumonia, urinary tract infection) requiring hospitalization within 1 month prior to surgery. * Inflammatory bowel disease (IBD), including ulcerative colitis, Crohn's disease, or colitis. * Acute gastroenteritis. * Clostridium difficile or Helicobacter pylori infection. * Chronic constipation. * Peptic ulcer. * Polyps in the stomach or intestines. * Gastrointestinal neoplasms. * Abdominal hernia. * Irritable bowel syndrome. * Acute or chronic cholecystitis, hepatitis. * Patients who died intraoperatively or within 24 hours postoperatively. * Patients with digestive system tumors. * Pregnancy or breastfeeding could affect postoperative medication use and study observations. * Involvement in other studies that may interfere with the objective results of this study.
Where this trial is running
Lanzhou, Gansu
- Hepatopancreatobiliary Surgery Institute of Gansu Province — Lanzhou, Gansu, China (Recruiting)
Study contacts
- Principal investigator: Wenbo Meng — Hepatopancreatobiliary Surgery Institute of Gansu Province
- Study coordinator: Wenbo Meng
- Email: mengwb@lzu.edu.cn
- Phone: 13919177177
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.