Ileus PostoperativeNCT07589465
Oral Lactulose for Gastrointestinal Recovery After Complex Appendectomy
A study testing Lactulose oral solution in people with Ileus Postoperative and Gastrointestinal Function, run by Nanchong Central Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileus Postoperative, Gastrointestinal Function, Complicated Appendicitis
- What is being tested?
- Lactulose oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2026to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital Nanchong Hospital Affiliated to Capital Medical University, Nanchong, Sichuan 637000
Sichuan, 637000
Tian YunHong, Doctor, 86+13508087719, drtianyunhong@126.com
About this study
Official title: Oral Lactulose for Postoperative Gastrointestinal Recovery After Complex Appendectomy: A Prospective Triple-Blind Placebo-Controlled Single-Center Randomized Trial
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.
- Being tested
- Lactulose oral solution, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactulose oral solutionDrug
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.
PlaceboDrug
Placebo (5% glucose solution) 20 mL on postoperative day 1 and 20 mL on postoperative day 2. Matching appearance, volume, and schedule with lactulose.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 days postoperatively
Secondary outcomes (6)
Time to first flatus after surgery
Measured: Up to 30 days postoperatively
Defecation rate within 72 hours postoperatively
Measured: Up to 30 days postoperatively
Length of postoperative hospital stay
Measured: Up to 30 days postoperatively
Postoperative abdominal pain VAS score on days 1, 3, and 7
Measured: Up to 30 days postoperatively
Incidence of postoperative ileus
Measured: Up to 30 days postoperatively
Incidence of postoperative nausea and vomiting
Measured: Up to 30 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start21 Jun 2026 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileus PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanchong Central Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589465
- Sponsor's protocol ID
- 2026 Review No. (049)
- Status last verified
- Jun 2026
- First submitted
- 9 May 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Lactulose for Postoperative Gastrointestinal Recovery After Complex Appendectomy: A Prospective Triple-Blind Placebo-Controlled Single-Center Randomized Trial
- ClinicalTrials.gov ID
- NCT07589465
- Acronym / sponsor ID
- 2026 Review No. (049)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nanchong Central HospitalOther government
- Study start
- 21 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 15 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactulose Group | Experimental | Drug: Lactulose oral solutionPatients 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 Group | Placebo comparator | Drug: PlaceboPatients receive oral placebo (5% glucose solution) 20 mL on postoperative day 1 and 20 mL on postoperative day 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactulose oral solutionLactulose 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 | Lactulose Group |
| PlaceboPlacebo (5% glucose solution) 20 mL on postoperative day 1 and 20 mL on postoperative day 2. Matching appearance, volume, and schedule with lactulose. | Drug | Placebo Group |
Primary outcome
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
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
Related trials for Ileus Postoperative
RecruitingObservational study
At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
Pain, Postoperative, Postoperative Ileus
Not yet recruitingPhase 2
TU-100 for Accelerating GI Recovery After Major Abdominopelvic Surgery (RC & CAWR)
Delay in GI Recovery/Postoperative Ileus (POI)
Not yet recruiting
Intraperitoneal Saline Irrigation in Cesarean Section
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactulose oral solution in people with Ileus Postoperative and Gastrointestinal Function, run by Nanchong Central Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tian YunHong (86+13508087719, drtianyunhong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.