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

November 26, 2018 updated by: zebing Zheng, Zunyi Medical College

Mutil-institutions Comparing Antibiotic Therapy With Laparscopic Appendectomy in Pediatric Chronic Appendicitis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • children's hospital of Guiyang
      • Zunyi, Guizhou, China, 563000
        • Affiliated Hospital of Zunyi Medical University
      • Zunyi, Guizhou, China, 563000
        • The first people hospital of zunyi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year
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.
30 days
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.
7days
Diarrhea
Time Frame: 7 days
Adverse effects of the antibiotic treatment during the conservation treatment
7 days
Incisional hernia
Time Frame: 1 year
Postintervention complication included incisional hernia occurring within1year after the operative procedure as diagnosed by surgeon .
1 year
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.
1 year
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 .
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zunyi Medical College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: yuanmei Liu, Zunyi Medical College
  • 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 Anshun City of Guizhou Province
  • Study Director: Xuanzao Wu, MD, Medical university of Guizhou
  • Study Director: Guohong Yang, people hospital of Suiyang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZunyiMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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