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NCT Number: NCT07589465

Oral Lactulose for Gastrointestinal Recovery After Complex Appendectomy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Sichuan, 637000, China

Location status: Recruiting

Location contact

Tian YunHong, Doctor

CONTACT

[email protected]

86+13508087719

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

    Time frame: Up to 7 days postoperatively

Secondary outcomes

  1. Time to first flatus after surgery

    Time frame: Up to 30 days postoperatively

  2. Defecation rate within 72 hours postoperatively

    Time frame: Up to 30 days postoperatively

  3. Length of postoperative hospital stay

    Time frame: Up to 30 days postoperatively

  4. Postoperative abdominal pain VAS score on days 1, 3, and 7

    Time frame: Up to 30 days postoperatively

  5. Incidence of postoperative ileus

    Time frame: Up to 30 days postoperatively

  6. Incidence of postoperative nausea and vomiting

    Time frame: Up to 30 days postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Tian YunHong

CONTACT

[email protected]

86+13508087719

Sponsors and collaborators

Lead sponsor

Nanchong Central Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 15, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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