Actively Recruiting
Oral Lactulose for Postoperative Gastrointestinal Recovery After Complex Appendectomy: A Prospective Triple-Blind Placebo-Controlled Randomized Trial
Led by Nanchong Central Hospital · Updated on 2026-05-15
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating oral lactulose to see if it helps improve bowel function recovery after surgery in people with complicated appendicitis. This prospective, triple-blind, placebo-controlled clinical trial aims to assess the safety and effectiveness of early lactulose treatment following appendectomy. The study will enroll adult patients aged 18 years and older who have confirmed complicated appendicitis based on specific scoring, surgical findings, or pathology. Participants will be randomly assigned to receive either oral lactulose or a placebo on the first and second days after surgery. Lactulose is given as 20 mL doses on postoperative days 1 and 2, with continued daily dosing if bowel activity does not resume by day 3. The placebo group receives a matching 5% glucose solution following the same schedule. This design allows comparison of lactulose's impact on gastrointestinal recovery after complex appendectomy. During the study, researchers will monitor patients' time to key bowel function milestones, such as first bowel movement or tolerance of solid food, as well as other measures like time to first gas passage, nausea, vomiting, hospital stay length, and any treatment-related side effects. The main outcome is the time until patients achieve GI-2, which marks recovery of gastrointestinal function. Participants will be closely followed up to 30 days after surgery to assess all outcomes and safety. A total of 150 patients will take part, contributing data to optimize postoperative care for complicated appendicitis.
CONDITIONS
Brief Title
Oral Lactulose for Gastrointestinal Recovery After Complex Appendectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed complicated appendicitis by SAS 2.0 score, surgical findings, or pathology
- Scheduled for appendectomy (open or laparoscopic)
- Able to give informed consent and comply with follow-up
You will not qualify if you...
- Preoperative intestinal obstruction, inflammatory bowel disease, or intestinal tumor
- Planned postoperative fasting longer than 48 hours
- Known allergy or hypersensitivity to lactulose or placebo
- Severe organ dysfunction classified as ASA IV or higher
- Pregnant or breastfeeding
- Cognitive or psychiatric disorders that impair follow-up compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days postoperatively
Participants receive oral lactulose or placebo starting on postoperative day 1 to aid gastrointestinal recovery after appendectomy.
Daily visits or assessments during the first week after surgery
Duration - Up to 30 days postoperatively
Participants are monitored for gastrointestinal recovery and postoperative outcomes up to 30 days after surgery.
Follow-up visits or assessments up to 30 days after surgery
Trial Site Locations
Total: 1 location
1
Beijing Anzhen Hospital Nanchong Hospital Affiliated to Capital Medical University, Nanchong, Sichuan 637000
Sichuan, China, 637000
Actively Recruiting
Research Team
T
Tian YunHong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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