Oral Lactulose for Gastrointestinal Recovery After Complex Appendectomy

Nanchong Central Hospital

Status: Enrolling

Conditions: Ileus Postoperative; Gastrointestinal Function; Complicated Appendicitis

Treatments: Drug: Placebo; Drug: Lactulose oral solution

Study type: Interventional

Funder types: Other

Identifiers

NCT07589465

2026 Review No. (049)

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups, including a placebo group

Lactulose Group

Experimental group

Description:

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.

Treatment:

Drug: Lactulose oral solution

Placebo Group

Placebo Comparator group

Description:

Patients receive oral placebo (5% glucose solution) 20 mL on postoperative day 1 and 20 mL on postoperative day 2.

Treatment:

Drug: Placebo