Oral Lactulose for Gastrointestinal Recovery After Complex Appendectomy

NCT07589465 | Recruiting

• 1 other identifier: 2026 Review No. (049)
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Function; Complicated Appendicitis; Ileus Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Lactulose Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lactulose oral solution DRUG

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.

Lactulose Group

Placebo DRUG

Placebo (5% glucose solution) 20 mL on postoperative day 1 and 20 mL on postoperative day 2. Matching appearance, volume, and schedule with lactulose.

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanchong Central Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital Nanchong Hospital Affiliated to Capital Medical University, Nanchong, Sichuan 637000

Sichuan, 637000, China

RECRUITING

MeSH Terms

Interventions

Lactulose

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Central Study Contacts

Tian YunHong

CONTACT

86+13508087719; drtianyunhong@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 15, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

CN (1)