Direct Visualization ERAT vs. Laparoscopic Appendectomy for Adults with Simple Appendicitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label, randomized non-inferiority trial compares ERAT, a minimally invasive endoscopic treatment to drain infection and clear blockage, with the standard laparoscopic removal of the appendix. About 376 adults across 14 hospitals in China are enrolled and assigned 1:1 to ERAT or laparoscopic appendectomy within 24 hours of admission. Key outcomes include 30-day treatment success, symptom resolution, and absence of recurrence, with follow-up visits at 2 weeks and phone follow-ups through 12 months. Eligibility requires CT-confirmed first-episode acute uncomplicated appendicitis and suitable suitability for either procedure. Exclusions include complicated disease, bowel obstruction, intolerance to bowel prep or colonoscopy, poor general condition, or concurrent trial participation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years.
2. Diagnosis of first-episode acute uncomplicated appendicitis (AUA) confirmed by CT scan of the lower abdomen. AUA is defined as acute appendicitis without evidence of abscess, perforation, gangrene, or tumor.
3. Provision of written informed consent.

Exclusion Criteria:

1. Complicated appendicitis, defined as acute appendicitis with perforation, gangrene, periappendiceal abscess or phlegmon, generalized peritonitis, or radiologic evidence of extraluminal appendicolith, extraluminal air, periappendiceal fat stranding, or appendiceal mass.
2. Severe intestinal adhesions or bowel obstruction.
3. Intolerance or contraindication to bowel preparation or colonoscopy (e.g., intestinal perforation or bowel obstruction).
4. Poor general condition precluding tolerance of abdominal surgery.
5. Abdominal pain caused by other diseases as confirmed by CT or other diagnostic examinations, including inflammatory bowel disease, urinary tract disease, or gynecological disease.
6. Pregnancy.
7. Severe dysfunction of major organ systems, including but not limited to cardiac, pulmonary, renal, hepatic, or hematologic systems.
8. Current enrollment in another clinical trial.
9. Any condition that may prevent the participant from completing all study requirements.

Where it's running

• Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-Sen University
  Guangzhou, Guangdong, China Recruiting
• Department of Gastroenterology, South China Hospital, Medical School, Shenzhen University
  Shenzhen, Guangdong, China Recruiting
• Department of Gastroenterology, The First Affiliated Hospital of Henan University,
  Kaifeng, Henan, China Recruiting
• Department of Gastroenterology, The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting
• Department of Gastrointestinal Surgery, Hunan Provincial People's Hospital
  Changsha, Hunan, China Recruiting
• Department of Gastrointestinal Surgery, Xiangya Hospital, Central South University
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Zhuan Liao, MD, PhD
• Email: liaozhuan@smmu.edu.cn
• Phone: 021-81873001

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant chemoradiotherapy with QL1706 for MSS low-rectal cancer

  This trial tests whether adding QL1706 to pre-surgery chemoradiotherapy helps people with MSS low-rectal cancer see complete tumor disappearance or better outcomes.

  Recruiting Phase 2/3 Changhai Hospital · Shanghai, Shanghai Municipality · NCT07866313

• Hetrombopag to prevent chemotherapy-related low platelets in gastrointestinal tumors

  This study will try hetrombopag to prevent low platelet counts in adults with gastrointestinal cancers who had platelet drops from prior chemotherapy.

  Recruiting Phase 2 Changhai Hospital · Shanghai · NCT07492693

• Fecal microbiota transplant to prevent infections after late-phase severe acute pancreatitis

  This trial will test whether giving healthy donor gut bacteria (fecal microbiota transplantation) through a feeding tube in the late phase of moderately severe or severe acute pancreatitis can prevent infectious complications.

  Recruiting Changhai Hospital · Fuzhou, Fujian and 11 other locations · NCT07464392

• Image collection for early upper gastrointestinal cancer and precancerous conditions

  This project will collect capsule endoscopy, endoscopy, CT, and biopsy images from adults with early upper gastrointestinal cancer or precancerous conditions to build an image database to support better image-based diagnosis.

  Recruiting Changhai Hospital · Shanghai · NCT07462247

• AI-guided decision support for managing pancreatic conditions

  This project will test an AI tool that reads contrast-enhanced CT scans to help doctors decide whether people with suspected pancreatic disease need surgery, close monitoring, or routine follow-up.

  Recruiting Changhai Hospital · Shanghai · NCT07439757

• CAR-NK cell therapy (CL-NK-003) for pancreatic cancer

  This will test a fixed dose of CAR‑NK cells (CL‑NK‑003) in adults with locally advanced, metastatic, or recurrent pancreatic cancer whose tumors show high eGR1 expression.

  Recruiting Phase 1 Changhai Hospital · Shanghai · NCT07425483

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.