About this trial
This is a prospective, triple-blind, placebo-controlled, single-center randomized clinical trial to evaluate the efficacy and safety of early oral lactulose for promoting postoperative gastrointestinal functional recovery in patients undergoing appendectomy for complicated appendicitis. Eligible patients aged ≥18 years with complicated appendicitis confirmed by preoperative SAS 2.0 score, intraoperative findings, or postoperative pathology will be randomly assigned 1:1 to receive oral lactulose or placebo on postoperative day 1 and day 2. The primary outcome is time to GI-2 (time from surgery to the later of first defecation or first tolerance of solid food). Secondary outcomes include time to first flatus, defecation rate within 72 hours, postoperative nausea and vomiting, length of hospital stay, medical costs, postoperative complications, and lactulose-related adverse events. A total of 150 patients will be enrolled. This study aims to provide high-level evidence for optimizing postoperative management in patients with complicated appendicitis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Lactulose oral solution
DrugLactulose oral solution 20mL on postoperative day 1, 20mL on postoperative day 2. If no flatus or defecation by postoperative day 3, continue 20 mL once daily until gastrointestinal function recovery.
Placebo
DrugPlacebo (5% glucose solution) 20 mL on postoperative day 1 and 20 mL on postoperative day 2. Matching appearance, volume, and schedule with lactulose.
Treatment groups
Trial outcomes
Primary outcomes
Time to GI-2 (hours): time from end of surgery to the later of first defecation (≥50 g) or first tolerance of solid diet without vomiting or abdominal distension.
Secondary outcomes
Time to first flatus after surgery
Defecation rate within 72 hours postoperatively
Length of postoperative hospital stay
Postoperative abdominal pain VAS score on days 1, 3, and 7
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