Appendicitis Clinical Trials

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Direct Visualization Endoscopic Retrograde Appendicitis Therapy (ERAT) Versus Laparoscopic Appendectomy (LA) for Acute Uncomplicated Appendicitis in Adults (E-APPEND): An Open-Label, Multicenter, Randomized Controlled Non-Inferiority Trial

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

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

• 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.

Locations
Other Locations
China
Department of Gastrointestinal Surgery, Hunan Provincial People's Hospital
RECRUITING
Changsha
Department of Gastrointestinal Surgery, Xiangya Hospital, Central South University
RECRUITING
Changsha
Department of Gastrointestinal Surgery, Fourth West China Hospital, Sichuan University
RECRUITING
Chengdu
Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-Sen University
RECRUITING
Guangzhou
Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Department of Gastroenterology, Jilin City People's Hospital
RECRUITING
Jilin City
Department of Gastroenterology, The First Affiliated Hospital of Henan University,
RECRUITING
Kaifeng
Department of Gastroenterology, Linyi People's Hospital
RECRUITING
Linyi
Department of Gastroenterology, The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Department of Gastroenterology, Changhai Hospital, Naval Medical University
RECRUITING
Shanghai
Department of Gastroenterology, South China Hospital, Medical School, Shenzhen University
RECRUITING
Shenzhen
Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Soochow University
NOT_YET_RECRUITING
Suzhou
Department of Gastroenterology, The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Zhuan Liao, MD, PhD
liaozhuan@smmu.edu.cn
021-81873001
Backup
Saif Ullah, MD, PhD
saif_ullah@zzu.edu.cn
008615538100231
Time Frame
Start Date: 2025-12-10
Estimated Completion Date: 2027-11
Participants
Target number of participants: 376
Treatments
Experimental: Direct Visualization ERAT
Undergo direct visualization endoscopic retrograde appendicitis therapy
Active_comparator: Laparoscopic Appendectomy
Undergo laparoscopic appendectomy
Sponsors
Leads: Changhai Hospital
Collaborators: MICRO-TECH (Nanjing) Co., Ltd

This content was sourced from clinicaltrials.gov