Oral Lactulose to Help GI Recovery After Complicated Appendicitis
Official title: Oral Lactulose for Postoperative Gastrointestinal Recovery After Complex Appendectomy: A Prospective Triple-Blind Placebo-Controlled Single-Center Randomized Trial
Run by Nanchong Central Hospital · NCT07589465 · Data updated 2026-11-12
This trial tests whether giving lactulose by mouth after appendectomy helps people recover bowel function faster than a placebo.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Nanchong Central Hospital Government |
| Locations | 1 site (Sichuan) |
| Status | Recruiting |
| Started | June 21, 2026 |
| Main results expected | June 30, 2029 |
| Study ends | June 30, 2029 |
| Registry record updated | June 25, 2026 |
| Trial ID | NCT07589465 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) undergoing open or laparoscopic surgery for complicated appendicitis with consent and ability to follow up.
✕Probably not a fit
Patients with preexisting intestinal obstruction, inflammatory bowel disease, tumors, or other exclusion criteria may not benefit and could be at higher risk for adverse events.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this single-center, triple-blind, randomized study, adults undergoing appendectomy for complicated appendicitis will receive lactulose or a placebo on postoperative days 1 and 2. The main goal is to see how long it takes until the patient can tolerate solids or have their first bowel movement (GI-2). Secondary outcomes include time to first flatulence, 72-hour defecation rate, nausea/vomiting, length of hospital stay, costs, complications, and any lactulose-related side effects. Researchers will enroll 150 participants and compare outcomes between the two groups to determine if early oral lactulose can promote faster gastrointestinal recovery. The trial is designed to provide high-quality evidence to guide postoperative care in this setting.
Why it matters
Potential benefit: If successful, patients may recover GI function faster, potentially shortening hospital stays and improving comfort after surgery.
How similar studies have gone: Previous research on gut motility agents after abdominal surgery has shown mixed results; this design aims to provide clearer, high-level evidence for lactulose.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.Age ≥18 years.2.Complicated appendicitis confirmed by SAS2.0 score, intraoperative findings, or pathology.3.Undergoing appendectomy (open or laparoscopic).4.Able to provide informed consent and comply with follow-up. Exclusion Criteria: * 1.Preoperative intestinal obstruction, IBD, or intestinal tumor.2.Planned postoperative fasting \>48 hours.3.Hypersensitivity to lactulose or placebo.4.Severe organ dysfunction (ASA ≥IV).5.Pregnancy or lactation.6.Cognitive or psychiatric disorder impairing follow-up.
Where it's running
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Beijing Anzhen Hospital Nanchong Hospital Affiliated to Capital Medical University, Nanchong, Sichuan 637000
Sichuan, China Recruiting
Study contacts
- Study coordinator: Tian YunHong
- Email: drtianyunhong@126.com
- Phone: 86+13508087719
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.