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Acute Uncomplicated AppendicitisE-APPENDNCT07230379

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

A study testing Direct Visualization Endoscopic Retrograde Appendicitis Therapy and Laparoscopic appendectomy in people with Acute Uncomplicated Appendicitis, run by Changhai Hospital at 14 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Uncomplicated Appendicitis
What is being tested?
Direct Visualization Endoscopic Retrograde Appendicitis Therapy and Laparoscopic appendectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
376 participants
Where
14 sitesChina
Study dates
10 Dec 2025to Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Zhuan Liao, MD, PhD contact

021-81873001

liaozhuan@smmu.edu.cn

Saif Ullah, MD, PhD contact

008615538100231

saif_ullah@zzu.edu.cn

14 sites in 1 country

China14 sites, 14 recruiting
  • Department of Gastrointestinal Surgery, Hunan Provincial People's Hospital

    Changsha, Hunan, 410005

    Chao-Wu Chen, MD, PhD, 008613298682898, dr.chencw@hunnu.edu.cn

    Chao-Wu Chen, MD, PhD

    Recruiting
  • Department of Gastrointestinal Surgery, Xiangya Hospital, Central South University

    Changsha, Hunan, 410008

    Wei-Dong Liu, MD, PhD, 008613873124855, davidcsu@foxmail.com

    Weo-Dong iu, MD, PhD

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

    Chengdu, Sichuan, 610041

    Juan Liao, MD, PhD, 00618780267956, juanliao@scu.edu.cn

    Juan Liao, MD, PhD

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

    Chongqing, Chingqing, 400010

    Song He, MD, PhD, 13808336120, hedoctor65@cqmu.edu.cn

    Song he, MD, PhD

    Not yet recruiting
  • Department of Gastrointestinal Surgery, The Sixth Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510655

    Zhen He, MD, PhD

    Zhen He, MD, PhD

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

    Hangzhou

    Ji-Chao Qin, MD, PhD, 008613628683363, jcqin2024@zju.edu.cn

    Ji-Chao Qin, MD, PhD

    Recruiting
  • Department of Gastroenterology, Jilin City People's Hospital

    Jilin City, Jilin, 132011

    Hong-Guang Wang, MD, PhD, 008618904421817, wanghongguang1817@163.com

    Liying Tao, MD, PhD, 13689866436, 406346148@qq.com

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

    Kaifeng, Henan, 475001

    Wen-Yi Yang, MD, PhD, 008615890922163, baoca4621210@163.com

    Wen-Yi Yang, MD, PhD

    Recruiting
  • Department of Gastroenterology, Linyi People's Hospital

    Linyi, Shandong, 276000

    Ling-Jian Kong, MD, PhD, 0086157 1369 8818, konggewww@163.com

    Ling-Jian Kong, MD, PhD

    Recruiting
  • Department of Gastroenterology, The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Yin Zhu, MD, PhD, 008613970841464, zhuyin27@sina.com

    Yin Zhu, MD, PhD

    Recruiting
  • Department of Gastroenterology, Changhai Hospital, Naval Medical University

    Shanghai, 200433

    Zhuan Liao, MD, PhD, liaozhuan@smmu.edu.cn

    Zhuan Liao, MD, PhD

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

    Shenzhen, Guangdong, 518116

    Si-Lin Huang, MD, PhD, 13512756686, silinhuang@szu.edu.cn

    Si-Lin Huang, MD, PhD

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

    Suzhou, Jiangsu, 215008

    Yong-You Wu, MD, PhD, 008613338706607, wuyongyou72@126.com

    Yong-You Wu, MD, PhD

    Not yet recruiting
  • Department of Gastroenterology, The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    Bing-Rong Liu, MD, PhD, 008613313695959, fccliubr@zzu.edu.cn

    Dan Liu, MD, PhD, 0086183 3980 0019, wilmawell@163.com

    Recruiting

Other trials in China

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
Direct Visualization Endoscopic Retrograde Appendicitis Therapy, Laparoscopic appendectomy
Keywords
ERAT, Endoscopic retrograde appendicitis therapy, Appendicitis, LA, Laparoscopic appendectomy
Medical subject headings
Appendicitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Direct Visualization Endoscopic Retrograde Appendicitis TherapyProcedure or surgery

    Also called ERAT

    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.

  • Laparoscopic appendectomyProcedure or surgery

    Also called LA

    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.

Study groups in NCT07230379
Study groupRoleWhat they receive
Direct Visualization ERATExperimentalUndergo direct visualization endoscopic retrograde appendicitis therapy
Receives: Procedure: Direct Visualization Endoscopic Retrograde Appendicitis Therapy
Laparoscopic AppendectomyActive comparatorUndergo laparoscopic appendectomy
Receives: Procedure: Laparoscopic appendectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 days

Secondary outcomes (17)
  1. 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.

    Measured: 1 year

  2. 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.

    Measured: Intraoperative

  3. 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.

    Measured: Pre-operative

  4. 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.

    Measured: Intraoperative

  5. 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.

    Measured: Intraoperative

  6. 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.

    Measured: Intraoperative

  7. Self-reported pain score

    Assessed using the Visual Analogue Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).

    Measured: 1 month

  8. 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.

    Measured: 1 week

  9. 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.

    Measured: 1 week

  10. 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.

    Measured: 2 weeks

  11. 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.

    Measured: 1 week

  12. Sick leave

    Number of days participants are absent from work due to disease-related reasons, including post-intervention recovery.

    Measured: 1 month

  13. 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.

    Measured: 1 month

  14. Cost of treatment

    Total direct hospital cost is calculated as the sum of all charges incurred, based on the hospital billing record.

    Measured: 1 year

  15. Quality of Life of the Participants

    Measured using the Chinese-validated EQ-5D-5L questionnaire.

    Measured: 1 year

  16. 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

    Measured: 1 year

  17. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2025
  2. Study start10 Dec 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
376 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07230379
Sponsor's protocol ID
E-APPEND
Acronym
E-APPEND
Status last verified
Nov 2025
First submitted
13 Nov 2025
Last updated
4 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Direct Visualization Endoscopic Retrograde Appendicitis Therapy and Laparoscopic appendectomy in people with Acute Uncomplicated Appendicitis, run by Changhai Hospital at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zhuan Liao, MD, PhD (021-81873001, liaozhuan@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Success (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.

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