Oral Lactulose for Gastrointestinal Recovery After Complex Appendectomy

Oral Lactulose for Postoperative Gastrointestinal Recovery After Complex Appendectomy: A Prospective Triple-Blind Placebo-Controlled Single-Center Randomized 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.

Study Overview

• Status: Recruiting
• Conditions: Complicated Appendicitis; Gastrointestinal Function; Ileus Postoperative
• Intervention / Treatment: Drug: Lactulose oral solution; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tian YunHong; Phone Number: 86+13508087719; Email: drtianyunhong@126.com

Study Locations

• China
  • Sichuan, China, 637000
    • Recruiting
    • Beijing Anzhen Hospital Nanchong Hospital Affiliated to Capital Medical University, Nanchong, Sichuan 637000
    • Contact: Tian YunHong, Doctor; Phone Number: 86+13508087719; Email: drtianyunhong@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lactulose Group; Patients receive oral lactulose 20 mL on postoperative day 1 and 20 mL on postoperative day 2.If the patient has no defecation or flatus by postoperative day 3, lactulose 20 mL will be administered once daily until gastrointestinal function recovers.	Drug: Lactulose oral solution; Lactulose 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 Comparator: Placebo Group; Patients receive oral placebo (5% glucose solution) 20 mL on postoperative day 1 and 20 mL on postoperative day 2.	Drug: Placebo; Placebo (5% glucose solution) 20 mL on postoperative day 1 and 20 mL on postoperative day 2. Matching appearance, volume, and schedule with lactulose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Up to 7 days postoperatively

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to first flatus after surgery	Up to 30 days postoperatively
Defecation rate within 72 hours postoperatively	Up to 30 days postoperatively
Length of postoperative hospital stay	Up to 30 days postoperatively
Postoperative abdominal pain VAS score on days 1, 3, and 7	Up to 30 days postoperatively
Incidence of postoperative ileus	Up to 30 days postoperatively
Incidence of postoperative nausea and vomiting	Up to 30 days postoperatively

Collaborators and Investigators

• Sponsor: Nanchong Central Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: May 9, 2026
• First Submitted That Met QC Criteria: May 9, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Carbohydrates; Polysaccharides; Disaccharides; Oligosaccharides; Sugars; Lactulose
• Other Study ID Numbers: 2026 Review No. (049)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No