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Recruiting NCT07589465

Oral Lactulose for Gastrointestinal Recovery After Complex Appendectomy

No phase Interventional Ileus Postoperative Gastrointestinal Function Complicated Appendicitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lactulose oral solution, Placebo.
Who it may be relevant to
Registry conditions: Ileus Postoperative, Gastrointestinal Function, Complicated Appendicitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • 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. [Time frame: Up to 7 days postoperatively]
Secondary outcome measures (6)
  • Time to first flatus after surgery [Time frame: Up to 30 days postoperatively]
  • Defecation rate within 72 hours postoperatively [Time frame: Up to 30 days postoperatively]
  • Length of postoperative hospital stay [Time frame: Up to 30 days postoperatively]
  • Postoperative abdominal pain VAS score on days 1, 3, and 7 [Time frame: Up to 30 days postoperatively]
  • Incidence of postoperative ileus [Time frame: Up to 30 days postoperatively]
  • Incidence of postoperative nausea and vomiting [Time frame: Up to 30 days postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Beijing Anzhen Hospital Nanchong Hospital Affiliated to Capital Medical University, Nancho — Sichuan

Identifiers

NCT: NCT07589465 · 2026 Review No. (049)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗