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โ† Trials
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Direct Visualization ERAT Versus Laparoscopic Appendectomy in Adults With Acute Uncomplicated Appendicitis

RecruitingNAAges 18 Years - anyAllChanghai Hospital
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age โ‰ฅ 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.
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What it tests

  • Direct Visualization Endoscopic Retrograde Appendicitis Therapy
  • Laparoscopic appendectomy
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Where

14 sites
Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China
Department of Gastroenterology, South China Hospital, Medical School, Shenzhen University
Shenzhen, China
Department of Gastroenterology, The First Affiliated Hospital of Henan University,
Kaifeng, China
Department of Gastroenterology, The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Department of Gastrointestinal Surgery, Hunan Provincial People's Hospital
Changsha, China
Department of Gastrointestinal Surgery, Xiangya Hospital, Central South University
Changsha, China
Department of Gastrointestinal Surgery, The Second Affiliated Hospital of Soochow University
Suzhou, China

โ€ฆand 6 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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