Appendicitis Clinical Trials

Find Appendicitis Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Anzhen Hospital Nanchong Hospital Affiliated to Capital Medical University, Nanchong, Sichuan 637000
RECRUITING
Sichuan
Contact Information
Primary
Tian YunHong
drtianyunhong@126.com
86+13508087719
Time Frame
Start Date: 2026-04-30
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 150
Treatments
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.
Placebo_comparator: Placebo Group
Patients receive oral placebo (5% glucose solution) 20 mL on postoperative day 1 and 20 mL on postoperative day 2.
Sponsors
Leads: Nanchong Central Hospital

This content was sourced from clinicaltrials.gov