Direct Visualization ERAT Versus Laparoscopic Appendectomy in Adults With Acute Uncomplicated Appendicitis

NCT07230379 | Not Yet Recruiting DMC

• 1 other identifier: E-APPEND
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 14

Brief Summary

This study compares two ways of treating acute uncomplicated appendicitis, which is a mild form of appendicitis. In the Direct Visualization ERAT group, participants will receive Endoscopic Retrograde Appendicitis Therapy (ERAT). This is a minimally invasive, non-surgical treatment that uses a flexible endoscope passed through the colon to reach the appendix, clear the blockage, and drain the infection. In the Surgery group, participants will undergo Laparoscopic Appendectomy (LA), which is the current standard surgical treatment to remove the appendix. The purpose of this study is to determine whether ERAT is as safe and effective as standard surgery for treating uncomplicated appendicitis. Before treatment, each participant will have a CT scan of the lower abdomen with contrast to confirm uncomplicated appendicitis and to rule out any signs of more serious infection. Participants will then be randomly assigned to either the ERAT group or the surgery group, and they will be informed of which treatment they will receive. Regardless of the group, all participants will receive the same supportive care, including pain relief, close monitoring, and a single dose of antibiotics before treatment. After the procedure, participants will stay in the hospital for at least 24 hours for observation. Follow-up will include an outpatient visit at 2 weeks, and telephone follow-ups at 1 month, 3 months, 6 months, and 1 year to monitor recovery and ensure that appendicitis does not recur.

Conditions

Acute Uncomplicated Appendicitis

Keywords

ERAT; Endoscopic retrograde appendicitis therapy; Appendicitis; LA; Laparoscopic appendectomy

Outcome Measures

Primary Outcomes (1)

• Treatment Success

  ERAT arm: Treatment success is defined as successful completion of the ERAT procedure, resolution of acute uncomplicated appendicitis symptoms, discharge from the hospital without appendectomy, and absence of recurrence within 30 days. LA arm: Treatment success is defined as successful completion of laparoscopic appendectomy without conversion to open appendectomy, histopathological confirmation of acute appendicitis characterized by the presence of neutrophilic infiltration within the appendiceal muscularis propria, resolution of acute uncomplicated appendicitis symptoms, and absence of recurrence within 30 days.

  30 days

Secondary Outcomes (17)

• Recurrence

  1 year

• Technical success

  Intraoperative

• Timing to procedure

  Pre-operative

• Total procedure time

  Intraoperative

• Intervention time

  Intraoperative

Study Arms (2)

Direct Visualization ERAT

EXPERIMENTAL

Undergo direct visualization endoscopic retrograde appendicitis therapy

Procedure: Direct Visualization Endoscopic Retrograde Appendicitis Therapy

Laparoscopic Appendectomy

ACTIVE COMPARATOR

Undergo laparoscopic appendectomy

Procedure: Laparoscopic appendectomy

Interventions

Direct Visualization Endoscopic Retrograde Appendicitis Therapy PROCEDURE

Direct visualization ERAT will be performed by experienced endoscopists (≥ 30 prior ERAT cases) under conscious sedation or general anesthesia as needed. A colonoscope with a transparent cap will be advanced to the cecum to expose the appendiceal orifice, and a direct visualization appendicoscope will be introduced through the working channel. The appendiceal lumen will be inspected and irrigated with saline to clear pus and debris, with negative pressure applied for aspiration. Small appendicoliths will be flushed out, while larger ones will be removed using a retrieval basket, stone extractor, or laser lithotripsy. When narrowing or heavy purulence is present, a stent will be inserted for drainage. After confirming adequate drainage, the scope will be withdrawn. If ERAT fails, conversion to laparoscopic or open appendectomy will be performed.

Also known as: ERAT

Direct Visualization ERAT

Laparoscopic appendectomy PROCEDURE

Laparoscopic appendectomy will be performed under general anesthesia by surgeons with experience in \> 20 procedures, according to standard clinical practice. The resected appendix will be examined for gross features and sent for histopathological confirmation of acute uncomplicated appendicitis. If laparoscopic appendectomy is unsuccessful, conversion to open appendectomy will be performed.

Also known as: LA

Laparoscopic Appendectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• 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.
• Provision of written informed consent.

You may not qualify if:

• 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.
• Severe intestinal adhesions or bowel obstruction.
• Intolerance or contraindication to bowel preparation or colonoscopy (e.g., intestinal perforation or bowel obstruction).
• Poor general condition precluding tolerance of abdominal surgery.
• Abdominal pain caused by other diseases as confirmed by CT or other diagnostic examinations, including inflammatory bowel disease, urinary tract disease, or gynecological disease.
• Pregnancy.
• Severe dysfunction of major organ systems, including but not limited to cardiac, pulmonary, renal, hepatic, or hematologic systems.
• Current enrollment in another clinical trial.
• Any condition that may prevent the participant from completing all study requirements.

Sponsors & Collaborators

• Changhai Hospital: lead
• Micro-Tech (Nanjing) Co., Ltd.: collaborator

Study Sites (14)

Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chingqing, 400010, China

Location

Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510655, China

Location

Department of Gastroenterology, South China Hospital, Medical School, Shenzhen University

Shenzhen, Guangdong, 518116, China

Location

Department of Gastroenterology, The First Affiliated Hospital of Henan University,

Kaifeng, Henan, 475001, China

Location

Department of Gastroenterology, The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

Department of Gastrointestinal Surgery, Hunan Provincial People's Hospital

Changsha, Hunan, 410005, China

Location

Department of Gastrointestinal Surgery, Xiangya Hospital, Central South University

Changsha, Hunan, 410008, China

Location

Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215008, China

Location

Department of Gastroenterology, The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Department of Gastroenterology, Jilin City People's Hospital

Jilin, Jilin, 132011, China

Location

Department of Gastroenterology, Linyi People's Hospital

Linyi, Shandong, 276000, China

Location

Department of Gastrointestinal Surgery, Fourth West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Location

Department of Gastroenterology, Changhai Hospital, Naval Medical University

Shanghai, 200433, China

Location

MeSH Terms

Conditions

Appendicitis

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Central Study Contacts

Zhuan Liao, MD, PhD

CONTACT

021-81873001; liaozhuan@smmu.edu.cn

Saif Ullah, MD, PhD

CONTACT

008615538100231; saif_ullah@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zhuan Liao

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (14)