An interventional study of Direct Visualization Endoscopic Retrograde Appendicitis Therapy and Laparoscopic appendectomy in Acute Uncomplicated Appendicitis, sponsored by Changhai Hospital. Recruiting at 14 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Changhai Hospital · Not applicable, Interventional, and Treatment
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.
This is a multicenter, open-label, randomized, non-inferiority trial comparing Direct Visualization Endoscopic Retrograde Appendicitis Therapy (ERAT) with Laparoscopic Appendectomy (LA) for the treatment of adult acute uncomplicated appendicitis (AUA). A total of 376 participants will be enrolled across 14 hospitals in China, and randomized in a 1:1 ratio to either ERAT or LA after providing informed consent.
Adults aged 18 years or older with CT-confirmed first-episode AUA are eligible. Key exclusions include complicated appendicitis, bowel obstruction, intolerance to colonoscopy or bowel preparation, poor operative candidacy, pregnancy, severe organ dysfunction, or concurrent participation in another clinical trial.
Interventions will be performed within 24 hours of admission. ERAT involves the use of a direct visualization appendicoscope to access the appendiceal lumen, irrigate pus and debris, and remove or fragment appendicoliths under direct vision. A short plastic stent may be placed if drainage is required. LA will be performed according to standard laparoscopic surgical techniques. Follow-up assessments will include an outpatient visit at 2 weeks and telephone follow-ups at 1, 3, 6, and 12 months.
The primary outcome is 30-day treatment success, defined as successful completion of the assigned procedure, resolution of symptoms, discharge without further surgery, and absence of recurrence. This study aims to provide robust evidence supporting the safety and effectiveness of ERAT and to inform future clinical guidelines for the management of acute uncomplicated appendicitis.
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 376 is above the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →Changhai Hospital is the lead sponsor of 355 studies on the registry; 137 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Undergo direct visualization endoscopic retrograde appendicitis therapy
Procedure: Direct Visualization Endoscopic Retrograde Appendicitis Therapy
Undergo laparoscopic appendectomy
Procedure: Laparoscopic appendectomy
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
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
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.
Time frame: 30 days
Recurrence
Recurrent appendicitis defined as the occurrence of clinical symptoms consistent with appendicitis, leading to appendectomy after initial intervention, with histopathological confirmation of appendicitis in the resected appendix.
Time frame: 1 year
Technical success
ERAT arm: Successful endoscopic cannulation of the appendiceal orifice with appendicoscope insertion. LA arm: Completion of laparoscopic appendectomy without conversion to open surgery.
Time frame: Intraoperative
Timing to procedure
Measured in hours from the time of CT-confirmed diagnosis of AUA to the start of the procedure, as documented in the operative note.
Time frame: Pre-operative
Total procedure time
Represents the total time patient spent in the OR. Measured in minutes from the time the patient is wheeled into the operating room to the time the patient is wheeled out.
Time frame: Intraoperative
Intervention time
Measured in minutes from the beginning to the end of the intervention procedure, based on the operative note. For ERAT: from endoscope insertion to complete scope withdrawal. For LA: from skin incision to skin closure.
Time frame: Intraoperative
Preparation time
Defined as total procedure time minus intervention time. This duration includes time spent on equipment setup, administration of anesthesia, patient positioning, and draping.
Time frame: Intraoperative
Self-reported pain score
Assessed using the Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
Time frame: 1 month
Time to soft diet resumption
Number of days from the end of the procedure to patient-reported good tolerance of a soft diet. If soft diet is tolerated on the same day as the procedure, it will be recorded as 0 days.
Time frame: 1 week
Post-intervention narcotics used
Total amount of narcotics received during the primary hospitalization, both oral and intravenous, converted into intravenous morphine equivalents per kilogram of body weight.
Time frame: 1 week
Duration of analgesics used
Number of days from the end of the procedure to the last dose of analgesics (oral or intravenous) used for procedure-related abdominal pain.
Time frame: 2 weeks
Duration of post-intervention antibiotics used
Number of days from the end of the procedure to the last dose of prescribed antibiotics. Antibiotics may include both intravenous and oral forms. The day of the procedure is counted as Day 0.
Time frame: 1 week
Sick leave
Number of days participants are absent from work due to disease-related reasons, including post-intervention recovery.
Time frame: 1 month
Time to return to normal daily activities
The number of days it takes for participants to resume their normal everyday activities without significant discomfort after receiving the treatment.
Time frame: 1 month
Cost of treatment
Total direct hospital cost is calculated as the sum of all charges incurred, based on the hospital billing record.
Time frame: 1 year
Quality of Life of the Participants
Measured using the Chinese-validated EQ-5D-5L questionnaire.
Time frame: 1 year
Patient Satisfaction
Measured by the Global Assessment of Satisfaction, consisting of two questions: 1. "How satisfied are you with the treatment you received for acute uncomplicated appendicitis?" Response on a 5-point Likert scale: very satisfied, satisfied, neutral, dissatisfied, very dissatisfied 2. "Knowing how the treatment went, would you recommend it to someone else?" Response: Yes or No
Time frame: 1 year
Complication
Complications are defined as any adverse event related to the intervention (ERAT or LA). They will be classified as major or minor based on severity, according to the Clavien-Dindo classification system, with major complications defined as Clavien-Dindo Grade II or higher.
Time frame: 1 year
Plan to share: Undecided — Undecided
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