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Antibiotic Therapy vs Laparscopic Appendectomy in Pediatric Chronic Appendicitis (ATvsLAAPT)

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ClinicalTrials.gov Identifier: NCT03754387
Recruitment Status : Enrolling by invitation
First Posted : November 27, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
zebing Zheng, Zunyi Medical College

Brief Summary:
This clinical trial will compare antibiotic therapy with laparoscopic appendectomy in the treatment of pediatric chronic appendicitis in china. Enrolled patients will be randomised and an allocation ratio of 1:1 will be made via weighted minimisation, where half of the patients will receive antibiotic therapy with intravenous Ceftazidime sodium, while the other half will have a laparoscopic appendicectomy.

Condition or disease Intervention/treatment Phase
Chronic Appendicitis Drug: Ceftazidime Procedure: appendectomy Not Applicable

Detailed Description:
In recent years, nonoperative treatment has challenged appendectomy as a first-line treatment of acute uncomplicated appendicitis by demonstrating its safety and short-term efficacy in adults. Several randomized controlled trials comparing appendectomy to antibiotics alone in children with acute uncomplicated appendicitis have been reported from other countries. These studies reveal that non-operative management of appendicitis is a safe treatment for appendicitis and is associated with a significantly lower risk of complications than appendectomy. However, the success rate of nonoperative management was 75% at 1year. Chronic appendicitis has been described as a possible cause of persistent right lower quadrant (RLQ) pain and laparoscopic appendectomy has been shown to benefit a large number of children,but there are no high-quality clinical trials. There are more than 200 million children in China. According to preliminary clinical data, the incidence of pediatric appendicitis in China is higher than Europe and America. Due to the Chinese parents have different cultures and educational backgrounds, more high-quality clinical trials are needed to guide parents to choose appropriate treatment for chronic appendicitis in children. Therefore, the investigators propose a multi-institutional trial in which patients and their families choose between antibiotics therapy (AT group) or laparoscopic appendectomy (LAAPT group) to chronic appendicitis in children aged 3-15 years. The investigators hypothesize that laparoscopic appendectomy will be successful in 90% of patients at 1 year follow-up and will be associated with fewer disability days, higher quality of life scores, and higher pain reduce scores than antibiotic therapy. This study will enroll 200 patients, age 3-15 years, with chronic appendicitis at 8-10 hospitals.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Mutil-institutions Comparing Antibiotic Therapy With Laparscopic Appendectomy in Pediatric Chronic Appendicitis
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Antibiotic therapy group
Ceftazidime will chosen as the antibiotic for this study because of its efficacy as a monotherapy for serious intraabdominal infections, requiring only a single, daily dose. Intravenous Ceftazidime sodium (50mg/kg/dose every 12 hours) is administered for 3 days to patients in the AT group, with the first dose given in the emergency department. The clinical status of patients in the AT group is reevaluated within 12 to 24 hours after admission by the surgeon on call. If the surgeon suspected progressive infection, perforated appendicitis, or peritonitis, the patient will underwent appendectomy. Intravenous antibiotic treatment will followed by 7 days of oral cefuroxime (250mg twice daily).
Drug: Ceftazidime
Patients choosing AT group were admitted to the hospital for observation and to receive intravenous antibiotics Intravenous Ceftazidime sodium (50mg/kg/dose every 12 hours) was administered for 3 days.

Experimental: Laparoscopic Appendectomy group
Laparoscopic appendectomy will performed using. Prophylactic antibiotics (ceftazidime sodium 50mg/kg/dose ) will administered approximately 30 minutes before the incision was made. No further antibiotics will given to patients in the surgical group unless a wound infection was suspected postoperatively.
Procedure: appendectomy
APPT group consisted of admission to the hospital with promptinitiation of intravenous antibiotics and appendectomy




Primary Outcome Measures :
  1. Success rate [ Time Frame: 1 year ]
    The primary end point for patients in the antibiotic therapy group is resolution of chronic appendicitis, resulting in discharge from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of 1 year (treatment efficacy). Treatment success in the laparoscopic appendectomy group is defined as a patient successfully undergoing an laparoscopic appendectomy and no recurrent abdominal pain during a minimum follow-up of 1 year (treatment efficacy).


Secondary Outcome Measures :
  1. The rate of recurrence [ Time Frame: 1 year ]
    late recurrence (after 1 year) of chronic appendicitis after conservative treatment, length of hospital stay and the amount of sick leave used by the patient.

  2. postintervention pain scores [ Time Frame: 1 year ]
    postintervention pain scores (VAS score range, 0-10; a score of 0 indicates no pain and 10 indicates the worst possible pain), and the use of pain medication.

  3. Wound infection [ Time Frame: 30 days ]
    Postintervention complications included clinical wound infection (surgical site infection) occurring within 30 days after the operative procedure as diagnosed by a surgeon or with a positive bacterial culture.

  4. pneumonia [ Time Frame: 7days ]
    Postintervention complication included pneumonia occurring within 7days after the operative procedure as diagnosed by clinical presentation and chest X-ray or CT-scan.

  5. Diarrhea [ Time Frame: 7 days ]
    Adverse effects of the antibiotic treatment during the conservation treatment

  6. Incisional hernia [ Time Frame: 1 year ]
    Postintervention complication included incisional hernia occurring within1year after the operative procedure as diagnosed by surgeon .

  7. Bowel obstruction [ Time Frame: 1 year ]
    Postintervention complication included bowel obstruction occurring within1year after the operative procedure as diagnosed by clinical presentation and abdominal X-ray or CT-scan.

  8. persistent abdominal or incisional pain [ Time Frame: 1 year ]
    Postintervention complication included persistent abdominal or incisional pain occurring within1year after the operative procedure as diagnosed by surgeon .



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Ages Eligible for Study:   3 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients were eligible if they were between 3 and 15 years of age, and they suffered from chronic appendicitis.
  2. US showing hyperemia and fecalith, ≤ 1.1 cm in diameter, compressible or non-compressible, no abscess, no phlegmon or CT showing hyperemia and fecalith, fat stranding, ≤ 1.1 cm in diameter, no abscess, no phlegmon.

Exclusion Criteria:

  1. Exclusion criteria consisted of (a history of) chronic back pain
  2. previous abdominal surgery (with the exception of diagnostic laparoscopies or a laparoscopic sterilization)
  3. specific gastro-intestinal entities (such as inflammatory bowel disease) 4.gynaecological disease (all female patients consulted a gynaecologist)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754387


Locations
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China, Guizhou
children's hospital of Guiyang
Guiyang, Guizhou, China, 550000
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China, 563000
The first people hospital of zunyi
Zunyi, Guizhou, China, 563000
Sponsors and Collaborators
Zunyi Medical College
Investigators
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Study Chair: yuanmei Liu Affiliated Hospital of Zunyi Medical University
Study Director: peihong Yan, MD Children's hospital of guiyang
Study Director: Shengli Gu, MD Zunyi First People's Hospital
Study Director: Lei Geng, MD Affiliated hospital of Binzhou
Study Director: Ziyong Li, MD Children's hospital of Dalian
Study Director: Guoqing He, MD People's Hospital of Guizhou Province
Study Director: Xuanzao Wu, MD Medical university of Guizhou
Study Director: Guohong Yang people hospital of Suiyang

Publications:
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Responsible Party: zebing Zheng, Head of pediatric surgery, Zunyi Medical College
ClinicalTrials.gov Identifier: NCT03754387     History of Changes
Other Study ID Numbers: ZunyiMU
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by zebing Zheng, Zunyi Medical College:
children
antibiotic therapy
laparoscopic appendectomy
randomized clinical trial(RCT)
Chronic appendicitis
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents
Antitubercular Agents
Appendicitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases
Ceftazidime
Antibiotics, Antitubercular