<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03754387</url>
  </required_header>
  <id_info>
    <org_study_id>ZunyiMU</org_study_id>
    <nct_id>NCT03754387</nct_id>
  </id_info>
  <brief_title>Antibiotic Therapy vs Laparscopic Appendectomy in Pediatric Chronic Appendicitis</brief_title>
  <acronym>ATvsLAAPT</acronym>
  <official_title>Mutil-institutions Comparing Antibiotic Therapy With Laparscopic Appendectomy in Pediatric Chronic Appendicitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zunyi Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zunyi Medical College</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial will compare antibiotic therapy with laparoscopic appendectomy in the&#xD;
      treatment of pediatric chronic appendicitis in china. Enrolled patients will be randomised&#xD;
      and an allocation ratio of 1:1 will be made via weighted minimisation, where half of the&#xD;
      patients will receive antibiotic therapy with intravenous Ceftazidime sodium, while the other&#xD;
      half will have a laparoscopic appendicectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, nonoperative treatment has challenged appendectomy as a first-line treatment&#xD;
      of acute uncomplicated appendicitis by demonstrating its safety and short-term efficacy in&#xD;
      adults. Several randomized controlled trials comparing appendectomy to antibiotics alone in&#xD;
      children with acute uncomplicated appendicitis have been reported from other countries. These&#xD;
      studies reveal that non-operative management of appendicitis is a safe treatment for&#xD;
      appendicitis and is associated with a significantly lower risk of complications than&#xD;
      appendectomy. However, the success rate of nonoperative management was 75% at 1year. Chronic&#xD;
      appendicitis has been described as a possible cause of persistent right lower quadrant (RLQ)&#xD;
      pain and laparoscopic appendectomy has been shown to benefit a large number of children，but&#xD;
      there are no high-quality clinical trials. There are more than 200 million children in China.&#xD;
      According to preliminary clinical data, the incidence of pediatric appendicitis in China is&#xD;
      higher than Europe and America. Due to the Chinese parents have different cultures and&#xD;
      educational backgrounds, more high-quality clinical trials are needed to guide parents to&#xD;
      choose appropriate treatment for chronic appendicitis in children. Therefore, the&#xD;
      investigators propose a multi-institutional trial in which patients and their families choose&#xD;
      between antibiotics therapy (AT group) or laparoscopic appendectomy (LAAPT group) to chronic&#xD;
      appendicitis in children aged 3-15 years. The investigators hypothesize that laparoscopic&#xD;
      appendectomy will be successful in 90% of patients at 1 year follow-up and will be associated&#xD;
      with fewer disability days, higher quality of life scores, and higher pain reduce scores than&#xD;
      antibiotic therapy. This study will enroll 200 patients, age 3-15 years, with chronic&#xD;
      appendicitis at 8-10 hospitals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success rate</measure>
    <time_frame>1 year</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The rate of recurrence</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>postintervention pain scores</measure>
    <time_frame>1 year</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound infection</measure>
    <time_frame>30 days</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pneumonia</measure>
    <time_frame>7days</time_frame>
    <description>Postintervention complication included pneumonia occurring within 7days after the operative procedure as diagnosed by clinical presentation and chest X-ray or CT-scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diarrhea</measure>
    <time_frame>7 days</time_frame>
    <description>Adverse effects of the antibiotic treatment during the conservation treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incisional hernia</measure>
    <time_frame>1 year</time_frame>
    <description>Postintervention complication included incisional hernia occurring within1year after the operative procedure as diagnosed by surgeon .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bowel obstruction</measure>
    <time_frame>1 year</time_frame>
    <description>Postintervention complication included bowel obstruction occurring within1year after the operative procedure as diagnosed by clinical presentation and abdominal X-ray or CT-scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>persistent abdominal or incisional pain</measure>
    <time_frame>1 year</time_frame>
    <description>Postintervention complication included persistent abdominal or incisional pain occurring within1year after the operative procedure as diagnosed by surgeon .</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Chronic Appendicitis</condition>
  <arm_group>
    <arm_group_label>Antibiotic therapy group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Laparoscopic Appendectomy group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ceftazidime</intervention_name>
    <description>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.</description>
    <arm_group_label>Antibiotic therapy group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>appendectomy</intervention_name>
    <description>APPT group consisted of admission to the hospital with promptinitiation of intravenous antibiotics and appendectomy</description>
    <arm_group_label>Laparoscopic Appendectomy group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients were eligible if they were between 3 and 15 years of age, and they suffered&#xD;
             from chronic appendicitis.&#xD;
&#xD;
          2. US showing hyperemia and fecalith, ≤ 1.1 cm in diameter, compressible or&#xD;
             non-compressible, no abscess, no phlegmon or CT showing hyperemia and fecalith, fat&#xD;
             stranding, ≤ 1.1 cm in diameter, no abscess, no phlegmon.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Exclusion criteria consisted of (a history of) chronic back pain&#xD;
&#xD;
          2. previous abdominal surgery (with the exception of diagnostic laparoscopies or a&#xD;
             laparoscopic sterilization)&#xD;
&#xD;
          3. specific gastro-intestinal entities (such as inflammatory bowel disease)&#xD;
             4.gynaecological disease (all female patients consulted a gynaecologist)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>yuanmei Liu</last_name>
    <role>Study Chair</role>
    <affiliation>Zunyi Medical College</affiliation>
  </overall_official>
  <overall_official>
    <last_name>peihong Yan, MD</last_name>
    <role>Study Director</role>
    <affiliation>Children's hospital of guiyang</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shengli Gu, MD</last_name>
    <role>Study Director</role>
    <affiliation>Zunyi First People's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lei Geng, MD</last_name>
    <role>Study Director</role>
    <affiliation>Affiliated hospital of Binzhou</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ziyong Li, MD</last_name>
    <role>Study Director</role>
    <affiliation>Children's hospital of Dalian</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guoqing He, MD</last_name>
    <role>Study Director</role>
    <affiliation>People's Hospital of Anshun City of Guizhou Province</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xuanzao Wu, MD</last_name>
    <role>Study Director</role>
    <affiliation>Medical university of Guizhou</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Guohong Yang</last_name>
    <role>Study Director</role>
    <affiliation>people hospital of Suiyang</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>children's hospital of Guiyang</name>
      <address>
        <city>Guiyang</city>
        <state>Guizhou</state>
        <zip>550000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Affiliated Hospital of Zunyi Medical University</name>
      <address>
        <city>Zunyi</city>
        <state>Guizhou</state>
        <zip>563000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The first people hospital of zunyi</name>
      <address>
        <city>Zunyi</city>
        <state>Guizhou</state>
        <zip>563000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Minneci PC, Mahida JB, Lodwick DL, Sulkowski JP, Nacion KM, Cooper JN, Ambeba EJ, Moss RL, Deans KJ. Effectiveness of Patient Choice in Nonoperative vs Surgical Management of Pediatric Uncomplicated Acute Appendicitis. JAMA Surg. 2016 May 1;151(5):408-15. doi: 10.1001/jamasurg.2015.4534.</citation>
    <PMID>26676711</PMID>
  </reference>
  <reference>
    <citation>Anderson KT, Bartz-Kurycki M, Austin MT, Kawaguchi A, John SD, Kao LS, Tsao K. Approaching zero: Implications of a computed tomography reduction program for pediatric appendicitis evaluation. J Pediatr Surg. 2017 Dec;52(12):1909-1915. doi: 10.1016/j.jpedsurg.2017.08.050. Epub 2017 Sep 5.</citation>
    <PMID>28927978</PMID>
  </reference>
  <reference>
    <citation>Salminen P, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Tuominen R, Hurme S, Virtanen J, Mecklin JP, Sand J, Jartti A, Rinta-Kiikka I, Gronroos JM. Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPAC Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2340-8. doi: 10.1001/jama.2015.6154.</citation>
    <PMID>26080338</PMID>
  </reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 18, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zunyi Medical College</investigator_affiliation>
    <investigator_full_name>zebing Zheng</investigator_full_name>
    <investigator_title>Head of pediatric surgery</investigator_title>
  </responsible_party>
  <keyword>children</keyword>
  <keyword>antibiotic therapy</keyword>
  <keyword>laparoscopic appendectomy</keyword>
  <keyword>randomized clinical trial(RCT)</keyword>
  <keyword>Chronic appendicitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ceftazidime</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03754387
org study id: ZunyiMU
nct id: NCT03754387
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Success rate
time frame: 1 year
description: 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).
measure: The rate of recurrence
time frame: 1 year
description: 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.
measure: postintervention pain scores
time frame: 1 year
description: 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.
measure: Wound infection
time frame: 30 days
description: 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.
measure: pneumonia
time frame: 7days
description: Postintervention complication included pneumonia occurring within 7days after the operative procedure as diagnosed by clinical presentation and chest X-ray or CT-scan.
measure: Diarrhea
time frame: 7 days
description: Adverse effects of the antibiotic treatment during the conservation treatment
measure: Incisional hernia
time frame: 1 year
description: Postintervention complication included incisional hernia occurring within1year after the operative procedure as diagnosed by surgeon .
measure: Bowel obstruction
time frame: 1 year
description: Postintervention complication included bowel obstruction occurring within1year after the operative procedure as diagnosed by clinical presentation and abdominal X-ray or CT-scan.
measure: persistent abdominal or incisional pain
time frame: 1 year
description: Postintervention complication included persistent abdominal or incisional pain occurring within1year after the operative procedure as diagnosed by surgeon .
arm group label: Antibiotic therapy group
arm group type: Active Comparator
description: 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).
arm group label: Laparoscopic Appendectomy group
arm group type: Experimental
description: 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.
intervention type: Drug
intervention name: Ceftazidime
description: 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.
arm group label: Antibiotic therapy group
intervention type: Procedure
intervention name: appendectomy
description: APPT group consisted of admission to the hospital with promptinitiation of intravenous antibiotics and appendectomy
arm group label: Laparoscopic Appendectomy group
criteria: 
gender: All
minimum age: 3 Years
maximum age: 15 Years
healthy volunteers: No
last name: yuanmei Liu
role: Study Chair
affiliation: Zunyi Medical College
last name: peihong Yan, MD
role: Study Director
affiliation: Children's hospital of guiyang
last name: Shengli Gu, MD
role: Study Director
affiliation: Zunyi First People's Hospital
last name: Lei Geng, MD
role: Study Director
affiliation: Affiliated hospital of Binzhou
last name: Ziyong Li, MD
role: Study Director
affiliation: Children's hospital of Dalian
last name: Guoqing He, MD
role: Study Director
affiliation: People's Hospital of Anshun City of Guizhou Province
last name: Xuanzao Wu, MD
role: Study Director
affiliation: Medical university of Guizhou
last name: Guohong Yang
role: Study Director
affiliation: people hospital of Suiyang
facility: 
facility: 
facility: 
country: China
citation: Minneci PC, Mahida JB, Lodwick DL, Sulkowski JP, Nacion KM, Cooper JN, Ambeba EJ, Moss RL, Deans KJ. Effectiveness of Patient Choice in Nonoperative vs Surgical Management of Pediatric Uncomplicated Acute Appendicitis. JAMA Surg. 2016 May 1;151(5):408-15. doi: 10.1001/jamasurg.2015.4534.
PMID: 26676711
citation: Anderson KT, Bartz-Kurycki M, Austin MT, Kawaguchi A, John SD, Kao LS, Tsao K. Approaching zero: Implications of a computed tomography reduction program for pediatric appendicitis evaluation. J Pediatr Surg. 2017 Dec;52(12):1909-1915. doi: 10.1016/j.jpedsurg.2017.08.050. Epub 2017 Sep 5.
PMID: 28927978
citation: Salminen P, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Tuominen R, Hurme S, Virtanen J, Mecklin JP, Sand J, Jartti A, Rinta-Kiikka I, Gronroos JM. Antibiotic Therapy vs Appendectomy for Treatment of Uncomplicated Acute Appendicitis: The APPAC Randomized Clinical Trial. JAMA. 2015 Jun 16;313(23):2340-8. doi: 10.1001/jama.2015.6154.
PMID: 26080338
responsible party type: Principal Investigator
investigator affiliation: Zunyi Medical College
investigator full name: zebing Zheng
investigator title: Head of pediatric surgery
mesh term: Appendicitis
mesh term: Ceftazidime
sharing ipd: No