<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/NCT04462588</url>
  </required_header>
  <id_info>
    <org_study_id>179</org_study_id>
    <nct_id>NCT04462588</nct_id>
  </id_info>
  <brief_title>Immature Granulocyte [IG] Count and Percentage for Medical Treatment of Uncomplicated Acute Appendicitis</brief_title>
  <acronym>[IG]</acronym>
  <official_title>Are the Changes in Immature Granulocyte Count and Percentage Significant in the Decision to Continue Medical Treatment of Uncomplicated Acute Appendicitis Cases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kahramanmaras Sutcu Imam University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kahramanmaras Sutcu Imam University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      After appendectomy was first described by Mcburney in 1889, it has been the most practiced&#xD;
      emergency surgery in the world with the lifetime incidence of acute appendicitis being&#xD;
      5%-25%. Most cases are uncomplicated cases without any complications and perforation&#xD;
      (20%-30%). Although appendectomy is still a curative therapy, medical treatment has come to&#xD;
      the fore in uncomplicated cases after improvements in imaging methods for diagnosing acute&#xD;
      appendicitis and especially the developments in antibiotherapy.&#xD;
&#xD;
      Medical treatment for acute appendicitis is, in fact, not a new condition. Practicing the&#xD;
      option of elective surgery following intravenous antibiotherapy for plastron appendicitis&#xD;
      that is among the complicated acute appendicitis has lead to further consideration of medical&#xD;
      treatment. A number of studies conducted for this purpose suggest that conservative treatment&#xD;
      in uncomplicated acute appendicitis may be a first-line treatment. Medical treatment of the&#xD;
      uncomplicated acute appendicitis prevents negative appendectomies, which indicates that&#xD;
      surgical removal of non-inflamed appendix ranging from 6% to 20%. In addition to preventing&#xD;
      unnecessary organ loss, it ensures eliminating postoperative complications such as intestinal&#xD;
      obstruction and wound site complications due to surgery.&#xD;
&#xD;
      Immature granulocytes (IG) are monitored in peripheral blood as immature polymorphonuclear&#xD;
      cells because of the activation of bone marrow. Although their counts can be determined&#xD;
      through direct inspection, they can be provided with automated systems within complete blood&#xD;
      count parameters as well as technological developments. The increase in their number&#xD;
      specifically suggests the activation of the bone marrow and can provide information about the&#xD;
      infectious process before leukocytosis is observed.&#xD;
&#xD;
      This study aimed to determine the importance of IG count and percentage to evaluate the role&#xD;
      of medical treatment and control its success in cases of uncomplicated acute appendicitis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After approval of local ethics committee (KSU Bioethics Committee, for the study with&#xD;
      protocol number 179; dated June 19, 2019; session no. 2019/11; and decision no.: 4), the&#xD;
      investigator's study was organized as a 1-year prospective randomized study. As a criterion&#xD;
      for terminating the study, the expiration of 1 year or reaching the total number of patients&#xD;
      obtained through power analysis. In the primary study endpoint, to detect a 20% difference&#xD;
      with α = 5% and ß = 20%, a total sample size of 64 patients was reported to be necessary for&#xD;
      achieving statistical significance.&#xD;
&#xD;
      Patients with the diagnosis of acute appendicitis over the age of 18 and treated by the same&#xD;
      surgical team were prospectively registered to Kahramanmaraş Sütçü Imam University General&#xD;
      Surgery Clinic between July 2019 and April 2020. Acute appendicitis was diagnosed with&#xD;
      history, physical examination results, laboratory results, and imaging methods&#xD;
      (Ultrasonography or Computed Tomography (CT)). As per these results, patients with Alvarado&#xD;
      Score 7 and above were diagnosed with acute appendicitis. Patients diagnosed with complicated&#xD;
      acute appendicitis based on imaging methods (such as perforation, periappendicular abscess&#xD;
      formation, and plastron formation), patients who are pregnant, patients who did not want to&#xD;
      be included were excluded from the study. Patients were informed that there were medical&#xD;
      treatment and surgical treatment options in uncomplicated acute appendicitis and written&#xD;
      consent was obtained from patients. For randomization purposes, patients were given balls to&#xD;
      draw. Using this ball drawing, patients were divided into two groups as those that would&#xD;
      receive random medical treatment (Group M) and those that would undergo direct appendectomy&#xD;
      (Group A) (Open appendectomy or laparoscopic appendectomy). Group M was divided into two&#xD;
      subgroups as those who responded to medical treatment within 24 h of follow-up and those who&#xD;
      failed medical treatment. The study was terminated as the total number of 64 patients was&#xD;
      reached because of power analysis.&#xD;
&#xD;
      In Group A, after examining the patient in the emergency, the patient was urgently taken to&#xD;
      operation to perform appendectomy (open or laparoscopic). A complete blood count and CRP were&#xD;
      studied on patients within the first 24 h of the postoperative course. In Group M, oral&#xD;
      intake was discontinued on admission of patients to the clinic and intravenous ciprofloxacin&#xD;
      (200 mg; twice a day) and metronidazole (500 mg; three times a day), which were effective for&#xD;
      both gram-positive and gram-negative bacteria and anaerobes, were started with fluid&#xD;
      replacement. When the duration of nonsurgical follow-up is between 12 and 24 h, there is no&#xD;
      increase in the perforation risk. Considerable complications can be encountered after 48 h&#xD;
      (wound site infections, wound decomposition, and other complications). Therefore, because of&#xD;
      increased risk of perforation and the likelihood of complications as a result, the response&#xD;
      protocol for medical treatment was restricted to 24 h. During follow-up, vital signs of&#xD;
      patients were verified every 6 h. At the 24th h of follow-up, the patients were asked for&#xD;
      their complaints and physical examinations were performed. Control of complete blood count,&#xD;
      CRP, and abdominal US were performed. At the 24th hour of the follow-up, Alvarado score was&#xD;
      repeated to patients. Patients who had no regression in the clinic and laboratory results&#xD;
      (with an Alvarado score ≥ 7 and who had an appendix unresponsive to medical treatment&#xD;
      according to imaging methods (with no change in diameter or increased or developed&#xD;
      complications) were considered to be unresponsive to conservative treatment and rescue&#xD;
      appendectomy was performed. Patients with a regression in physical examination and laboratory&#xD;
      results (with calculating Alvarado score &lt;7) and those with an appendix that responded to&#xD;
      medical treatment as per imaging methods (with reduced diameter or not monitored with US)&#xD;
      were considered to have responded to conservative treatment; and oral intake was initiated&#xD;
      without surgery. . They were discharged from the hospital with a prescription of 1-week oral&#xD;
      antibiotic regimen (a combination of oral ciprofloxacin 500 mg and oral metronidazole 500 mg&#xD;
      two times daily (morning and evening)). At the end of antibiotic therapy, patients were&#xD;
      called for control.&#xD;
&#xD;
      WBC count, neutrophil count, lymphocyte count, IG count and IG% were measured using an&#xD;
      automated hematological analyzer (XN 3000; Sysmex Corp., Kobe, Japan) and CRP levels were&#xD;
      measured using an automated biochemical analyzer (Cobas C-702 module, Roche Diagnostics,&#xD;
      Basel, Sweden) from blood samples obtained at the initial admission to the emergency&#xD;
      department and the 24th hour of the follow-up. Neutrophil to lymphocyte ratio (NLR) levels&#xD;
      were manually calculated. The IG fraction includes promyelocytes, myelocytes, and&#xD;
      metamyelocytes but not band neutrophils or myeloblasts. Moreover, DNI (IG percentage-%) is&#xD;
      the IG count to white blood cell ratio.&#xD;
&#xD;
      Statistical Evaluation: IBM Statistical Package for Social Sciences for windows, Version 20.0&#xD;
      software package (IBM Corp., Armonk, NY, USA) was used to evaluate statistical data.&#xD;
      Therefore, 64 patients were required to achieve 80% power to detect a difference of 10% among&#xD;
      IG count and percentage, the means using student t-test and repeated measures ANOVA at the 0.&#xD;
      05 significance level.&#xD;
&#xD;
      Kolmogorov-Smirnov test was performed for the suitability of patients for normal&#xD;
      distribution. Based on their suitability for normal distribution, paired sample t test was&#xD;
      used to evaluate intra-group measurements in numerical data, while student t-test and&#xD;
      Mann-Whitney U test were used in inter-group evaluation. Repeated measurement ANOVA and&#xD;
      Scheffe's post-hoc test were used to evaluate the relationship between subgroups and&#xD;
      appendectomy group. Note that Chi square test and Fischer's exact test were used to evaluate&#xD;
      the categorical data. Numerical data were given as median (minimum - maximum), and&#xD;
      categorical data were indicated in numbers (n) and percentages (%). Statistically, p&lt;0.05&#xD;
      values were considered to be significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">June 1, 2020</completion_date>
  <primary_completion_date type="Actual">June 1, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Medical treatment success</measure>
    <time_frame>Started with administration to the clinic and finished with the 24th hour of the follow up</time_frame>
    <description>Defining medical treatment success with immature granulocyte count (/mm3) comparing with appendectomy group's samples</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical treatment success</measure>
    <time_frame>Started with administration to the clinic and finished with the 24th hour of the follow up</time_frame>
    <description>Defining medical treatment success with immature granulocyte percentage (immature granulocyte count/total white blood cell count x100) comparing with appendectomy group's samples</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medical treatment continue</measure>
    <time_frame>Started with administration to the clinic and finished with the 24th hour of the follow up</time_frame>
    <description>Defining medical treatment success with immature granulocyte count (/mm3) comparing with appendectomy group's samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical treatment continue</measure>
    <time_frame>Started with administration to the clinic and finished with the 24th hour of the follow up</time_frame>
    <description>Defining medical treatment success with immature granulocyte percentage (immature granulocyte count/total white blood cell count x100) comparing with appendectomy group's samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical treatment continue</measure>
    <time_frame>ALVARADO Score in the first administration to the clinic and the 24th hour of the follow up</time_frame>
    <description>Defining medical treatment success with ALVARADO Score comparing with appendectomy group's samples for continuing the medical treatment options</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">64</enrollment>
  <condition>Acute Appendicitis Without Peritonitis</condition>
  <condition>Medical Emergencies</condition>
  <arm_group>
    <arm_group_label>Medical Treatment Group</arm_group_label>
    <description>Medical treatment group of uncomplicated acute appendisitis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgery</arm_group_label>
    <description>Operated group of uncomplicated acute appendisitis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cipro 400 MG in 200 ML Injection</intervention_name>
    <description>medical tratment group</description>
    <arm_group_label>Medical Treatment Group</arm_group_label>
    <other_name>Medical treatment of acute appendicitis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Flagyl I.V. RTU</intervention_name>
    <description>medical tratment group</description>
    <arm_group_label>Medical Treatment Group</arm_group_label>
    <other_name>Medical treatment of acute appendicitis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>appendectomy (open or laparascopic)</intervention_name>
    <description>appendectomy (open or laparascopic)</description>
    <arm_group_label>Surgery</arm_group_label>
    <other_name>Appendectomy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Uncomplicated acute appendicitis cases&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinically diagnosed uncomplicated acute appendisitis cases Uncomplicated acute&#xD;
        appendicitis cases who accepted the study protocol Successfully medical treated acute&#xD;
        appendicitis Operated uncomplicated acute appendicitis cases -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Clinically diagnosed complicated acute appendisitis cases Uncomplicated acute appendicitis&#xD;
        cases who do not accept the study protocol Patients with any type of malignancy (appendix&#xD;
        or other organ) Patients with rheumatologic disease or blood diseases&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Elder than 18 years old</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kahramanmaraş Sütçü İmam University</name>
      <address>
        <city>Kahramanmaraş</city>
        <zip>46000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Kirkil C, Yigit MV, Aygen E. Long-term results of nonoperative treatment for uncomplicated acute appendicitis. Turk J Gastroenterol. 2014 Aug;25(4):393-7. doi: 10.5152/tjg.2014.7192.</citation>
    <PMID>25254521</PMID>
  </reference>
  <reference>
    <citation>Okus A, Ay S, Karahan O, Eryilmaz MA, Sevinc B, Aksoy N. Monitoring C-reactive protein levels during medical management of acute appendicitis to predict the need for surgery. Surg Today. 2015 Apr;45(4):451-6. doi: 10.1007/s00595-014-1099-6. Epub 2014 Dec 27.</citation>
    <PMID>25542081</PMID>
  </reference>
  <reference>
    <citation>Unal Y. A new and early marker in the diagnosis of acute complicated appendicitis: immature granulocytes. Ulus Travma Acil Cerrahi Derg. 2018 Sep;24(5):434-439. doi: 10.5505/tjtes.2018.91661.</citation>
    <PMID>30394497</PMID>
  </reference>
  <reference>
    <citation>Salminen P, Tuominen R, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Hurme S, Mecklin JP, Sand J, Virtanen J, Jartti A, Gronroos JM. Five-Year Follow-up of Antibiotic Therapy for Uncomplicated Acute Appendicitis in the APPAC Randomized Clinical Trial. JAMA. 2018 Sep 25;320(12):1259-1265. doi: 10.1001/jama.2018.13201. Erratum In: JAMA. 2018 Oct 23;320(16):1711.</citation>
    <PMID>30264120</PMID>
  </reference>
  <reference>
    <citation>Becker P, Fichtner-Feigl S, Schilling D. Clinical Management of Appendicitis. Visc Med. 2018 Dec;34(6):453-458. doi: 10.1159/000494883. Epub 2018 Nov 24.</citation>
    <PMID>30675493</PMID>
  </reference>
  <reference>
    <citation>Wojciechowicz KH, Hoffkamp HJ, van Hulst RA. Conservative treatment of acute appendicitis: an overview. Int Marit Health. 2010;62(4):265-72.</citation>
    <PMID>21348022</PMID>
  </reference>
  <reference>
    <citation>Coccolini F, Fugazzola P, Sartelli M, Cicuttin E, Sibilla MG, Leandro G, De' Angelis GL, Gaiani F, Di Mario F, Tomasoni M, Catena F, Ansaloni L. Conservative treatment of acute appendicitis. Acta Biomed. 2018 Dec 17;89(9-S):119-134. doi: 10.23750/abm.v89i9-S.7905.</citation>
    <PMID>30561405</PMID>
  </reference>
  <reference>
    <citation>Karon BS, Tolan NV, Wockenfus AM, Block DR, Baumann NA, Bryant SC, Clements CM. Evaluation of lactate, white blood cell count, neutrophil count, procalcitonin and immature granulocyte count as biomarkers for sepsis in emergency department patients. Clin Biochem. 2017 Nov;50(16-17):956-958. doi: 10.1016/j.clinbiochem.2017.05.014. Epub 2017 May 25.</citation>
    <PMID>28552399</PMID>
  </reference>
  <reference>
    <citation>Nahm CH, Choi JW, Lee J. Delta neutrophil index in automated immature granulocyte counts for assessing disease severity of patients with sepsis. Ann Clin Lab Sci. 2008 Summer;38(3):241-6.</citation>
    <PMID>18715852</PMID>
  </reference>
  <reference>
    <citation>Unal Y, Barlas AM. Role of increased immature granulocyte percentage in the early prediction of acute necrotizing pancreatitis. Ulus Travma Acil Cerrahi Derg. 2019 Mar;25(2):177-182. doi: 10.14744/tjtes.2019.70679.</citation>
    <PMID>30892679</PMID>
  </reference>
  <reference>
    <citation>Park JS, Kim JS, Kim YJ, Kim WY. Utility of the immature granulocyte percentage for diagnosing acute appendicitis among clinically suspected appendicitis in adult. J Clin Lab Anal. 2018 Sep;32(7):e22458. doi: 10.1002/jcla.22458. Epub 2018 Apr 30.</citation>
    <PMID>29708633</PMID>
  </reference>
  <reference>
    <citation>Kirkil C, Karabulut K, Aygen E, Ilhan YS, Yur M, Binnetoglu K, Bulbuller N. Appendicitis scores may be useful in reducing the costs of treatment for right lower quadrant pain. Ulus Travma Acil Cerrahi Derg. 2013 Jan;19(1):13-9. doi: 10.5505/tjtes.2013.88714.</citation>
    <PMID>23588973</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kahramanmaras Sutcu Imam University</investigator_affiliation>
    <investigator_full_name>Mehmet Buğra Bozan</investigator_full_name>
    <investigator_title>Professor, Assistant</investigator_title>
  </responsible_party>
  <keyword>Uncomplicated Acute Appendisitis</keyword>
  <keyword>Alvarado Scoring System</keyword>
  <keyword>Immature Granulocyte Count</keyword>
  <keyword>Immature Granulocyte Percentage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</mesh_term>
    <mesh_term>Peritonitis</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Acute Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metronidazole</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/NCT04462588
org study id: 179
nct id: NCT04462588
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
After appendectomy was first described by Mcburney in 1889, it has been the most practiced
      emergency surgery in the world with the lifetime incidence of acute appendicitis being
      5%-25%. Most cases are uncomplicated cases without any complications and perforation
      (20%-30%). Although appendectomy is still a curative therapy, medical treatment has come to
      the fore in uncomplicated cases after improvements in imaging methods for diagnosing acute
      appendicitis and especially the developments in antibiotherapy.

      Medical treatment for acute appendicitis is, in fact, not a new condition. Practicing the
      option of elective surgery following intravenous antibiotherapy for plastron appendicitis
      that is among the complicated acute appendicitis has lead to further consideration of medical
      treatment. A number of studies conducted for this purpose suggest that conservative treatment
      in uncomplicated acute appendicitis may be a first-line treatment. Medical treatment of the
      uncomplicated acute appendicitis prevents negative appendectomies, which indicates that
      surgical removal of non-inflamed appendix ranging from 6% to 20%. In addition to preventing
      unnecessary organ loss, it ensures eliminating postoperative complications such as intestinal
      obstruction and wound site complications due to surgery.

      Immature granulocytes (IG) are monitored in peripheral blood as immature polymorphonuclear
      cells because of the activation of bone marrow. Although their counts can be determined
      through direct inspection, they can be provided with automated systems within complete blood
      count parameters as well as technological developments. The increase in their number
      specifically suggests the activation of the bone marrow and can provide information about the
      infectious process before leukocytosis is observed.

      This study aimed to determine the importance of IG count and percentage to evaluate the role
      of medical treatment and control its success in cases of uncomplicated acute appendicitis.
After approval of local ethics committee (KSU Bioethics Committee, for the study with
      protocol number 179; dated June 19, 2019; session no. 2019/11; and decision no.: 4), the
      investigator's study was organized as a 1-year prospective randomized study. As a criterion
      for terminating the study, the expiration of 1 year or reaching the total number of patients
      obtained through power analysis. In the primary study endpoint, to detect a 20% difference
      with α = 5% and ß = 20%, a total sample size of 64 patients was reported to be necessary for
      achieving statistical significance.

      Patients with the diagnosis of acute appendicitis over the age of 18 and treated by the same
      surgical team were prospectively registered to Kahramanmaraş Sütçü Imam University General
      Surgery Clinic between July 2019 and April 2020. Acute appendicitis was diagnosed with
      history, physical examination results, laboratory results, and imaging methods
      (Ultrasonography or Computed Tomography (CT)). As per these results, patients with Alvarado
      Score 7 and above were diagnosed with acute appendicitis. Patients diagnosed with complicated
      acute appendicitis based on imaging methods (such as perforation, periappendicular abscess
      formation, and plastron formation), patients who are pregnant, patients who did not want to
      be included were excluded from the study. Patients were informed that there were medical
      treatment and surgical treatment options in uncomplicated acute appendicitis and written
      consent was obtained from patients. For randomization purposes, patients were given balls to
      draw. Using this ball drawing, patients were divided into two groups as those that would
      receive random medical treatment (Group M) and those that would undergo direct appendectomy
      (Group A) (Open appendectomy or laparoscopic appendectomy). Group M was divided into two
      subgroups as those who responded to medical treatment within 24 h of follow-up and those who
      failed medical treatment. The study was terminated as the total number of 64 patients was
      reached because of power analysis.

      In Group A, after examining the patient in the emergency, the patient was urgently taken to
      operation to perform appendectomy (open or laparoscopic). A complete blood count and CRP were
      studied on patients within the first 24 h of the postoperative course. In Group M, oral
      intake was discontinued on admission of patients to the clinic and intravenous ciprofloxacin
      (200 mg; twice a day) and metronidazole (500 mg; three times a day), which were effective for
      both gram-positive and gram-negative bacteria and anaerobes, were started with fluid
      replacement. When the duration of nonsurgical follow-up is between 12 and 24 h, there is no
      increase in the perforation risk. Considerable complications can be encountered after 48 h
      (wound site infections, wound decomposition, and other complications). Therefore, because of
      increased risk of perforation and the likelihood of complications as a result, the response
      protocol for medical treatment was restricted to 24 h. During follow-up, vital signs of
      patients were verified every 6 h. At the 24th h of follow-up, the patients were asked for
      their complaints and physical examinations were performed. Control of complete blood count,
      CRP, and abdominal US were performed. At the 24th hour of the follow-up, Alvarado score was
      repeated to patients. Patients who had no regression in the clinic and laboratory results
      (with an Alvarado score ≥ 7 and who had an appendix unresponsive to medical treatment
      according to imaging methods (with no change in diameter or increased or developed
      complications) were considered to be unresponsive to conservative treatment and rescue
      appendectomy was performed. Patients with a regression in physical examination and laboratory
      results (with calculating Alvarado score <7) and those with an appendix that responded to
      medical treatment as per imaging methods (with reduced diameter or not monitored with US)
      were considered to have responded to conservative treatment; and oral intake was initiated
      without surgery. . They were discharged from the hospital with a prescription of 1-week oral
      antibiotic regimen (a combination of oral ciprofloxacin 500 mg and oral metronidazole 500 mg
      two times daily (morning and evening)). At the end of antibiotic therapy, patients were
      called for control.

      WBC count, neutrophil count, lymphocyte count, IG count and IG% were measured using an
      automated hematological analyzer (XN 3000; Sysmex Corp., Kobe, Japan) and CRP levels were
      measured using an automated biochemical analyzer (Cobas C-702 module, Roche Diagnostics,
      Basel, Sweden) from blood samples obtained at the initial admission to the emergency
      department and the 24th hour of the follow-up. Neutrophil to lymphocyte ratio (NLR) levels
      were manually calculated. The IG fraction includes promyelocytes, myelocytes, and
      metamyelocytes but not band neutrophils or myeloblasts. Moreover, DNI (IG percentage-%) is
      the IG count to white blood cell ratio.

      Statistical Evaluation: IBM Statistical Package for Social Sciences for windows, Version 20.0
      software package (IBM Corp., Armonk, NY, USA) was used to evaluate statistical data.
      Therefore, 64 patients were required to achieve 80% power to detect a difference of 10% among
      IG count and percentage, the means using student t-test and repeated measures ANOVA at the 0.
      05 significance level.

      Kolmogorov-Smirnov test was performed for the suitability of patients for normal
      distribution. Based on their suitability for normal distribution, paired sample t test was
      used to evaluate intra-group measurements in numerical data, while student t-test and
      Mann-Whitney U test were used in inter-group evaluation. Repeated measurement ANOVA and
      Scheffe's post-hoc test were used to evaluate the relationship between subgroups and
      appendectomy group. Note that Chi square test and Fischer's exact test were used to evaluate
      the categorical data. Numerical data were given as median (minimum - maximum), and
      categorical data were indicated in numbers (n) and percentages (%). Statistically, p<0.05
      values were considered to be significant.
observational model: Case-Only
time perspective: Prospective
measure: Medical treatment success
time frame: Started with administration to the clinic and finished with the 24th hour of the follow up
description: Defining medical treatment success with immature granulocyte count (/mm3) comparing with appendectomy group's samples
measure: Medical treatment success
time frame: Started with administration to the clinic and finished with the 24th hour of the follow up
description: Defining medical treatment success with immature granulocyte percentage (immature granulocyte count/total white blood cell count x100) comparing with appendectomy group's samples
measure: Medical treatment continue
time frame: Started with administration to the clinic and finished with the 24th hour of the follow up
description: Defining medical treatment success with immature granulocyte count (/mm3) comparing with appendectomy group's samples
measure: Medical treatment continue
time frame: Started with administration to the clinic and finished with the 24th hour of the follow up
description: Defining medical treatment success with immature granulocyte percentage (immature granulocyte count/total white blood cell count x100) comparing with appendectomy group's samples
measure: Medical treatment continue
time frame: ALVARADO Score in the first administration to the clinic and the 24th hour of the follow up
description: Defining medical treatment success with ALVARADO Score comparing with appendectomy group's samples for continuing the medical treatment options
arm group label: Medical Treatment Group
description: Medical treatment group of uncomplicated acute appendisitis
arm group label: Surgery
description: Operated group of uncomplicated acute appendisitis
intervention type: Drug
intervention name: Cipro 400 MG in 200 ML Injection
description: medical tratment group
arm group label: Medical Treatment Group
other name: Medical treatment of acute appendicitis
intervention type: Drug
intervention name: Flagyl I.V. RTU
description: medical tratment group
arm group label: Medical Treatment Group
other name: Medical treatment of acute appendicitis
intervention type: Procedure
intervention name: appendectomy (open or laparascopic)
description: appendectomy (open or laparascopic)
arm group label: Surgery
other name: Appendectomy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: Elder than 18 years old
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
citation: Kirkil C, Yigit MV, Aygen E. Long-term results of nonoperative treatment for uncomplicated acute appendicitis. Turk J Gastroenterol. 2014 Aug;25(4):393-7. doi: 10.5152/tjg.2014.7192.
PMID: 25254521
citation: Okus A, Ay S, Karahan O, Eryilmaz MA, Sevinc B, Aksoy N. Monitoring C-reactive protein levels during medical management of acute appendicitis to predict the need for surgery. Surg Today. 2015 Apr;45(4):451-6. doi: 10.1007/s00595-014-1099-6. Epub 2014 Dec 27.
PMID: 25542081
citation: Unal Y. A new and early marker in the diagnosis of acute complicated appendicitis: immature granulocytes. Ulus Travma Acil Cerrahi Derg. 2018 Sep;24(5):434-439. doi: 10.5505/tjtes.2018.91661.
PMID: 30394497
citation: Salminen P, Tuominen R, Paajanen H, Rautio T, Nordstrom P, Aarnio M, Rantanen T, Hurme S, Mecklin JP, Sand J, Virtanen J, Jartti A, Gronroos JM. Five-Year Follow-up of Antibiotic Therapy for Uncomplicated Acute Appendicitis in the APPAC Randomized Clinical Trial. JAMA. 2018 Sep 25;320(12):1259-1265. doi: 10.1001/jama.2018.13201. Erratum In: JAMA. 2018 Oct 23;320(16):1711.
PMID: 30264120
citation: Becker P, Fichtner-Feigl S, Schilling D. Clinical Management of Appendicitis. Visc Med. 2018 Dec;34(6):453-458. doi: 10.1159/000494883. Epub 2018 Nov 24.
PMID: 30675493
citation: Wojciechowicz KH, Hoffkamp HJ, van Hulst RA. Conservative treatment of acute appendicitis: an overview. Int Marit Health. 2010;62(4):265-72.
PMID: 21348022
citation: Coccolini F, Fugazzola P, Sartelli M, Cicuttin E, Sibilla MG, Leandro G, De' Angelis GL, Gaiani F, Di Mario F, Tomasoni M, Catena F, Ansaloni L. Conservative treatment of acute appendicitis. Acta Biomed. 2018 Dec 17;89(9-S):119-134. doi: 10.23750/abm.v89i9-S.7905.
PMID: 30561405
citation: Karon BS, Tolan NV, Wockenfus AM, Block DR, Baumann NA, Bryant SC, Clements CM. Evaluation of lactate, white blood cell count, neutrophil count, procalcitonin and immature granulocyte count as biomarkers for sepsis in emergency department patients. Clin Biochem. 2017 Nov;50(16-17):956-958. doi: 10.1016/j.clinbiochem.2017.05.014. Epub 2017 May 25.
PMID: 28552399
citation: Nahm CH, Choi JW, Lee J. Delta neutrophil index in automated immature granulocyte counts for assessing disease severity of patients with sepsis. Ann Clin Lab Sci. 2008 Summer;38(3):241-6.
PMID: 18715852
citation: Unal Y, Barlas AM. Role of increased immature granulocyte percentage in the early prediction of acute necrotizing pancreatitis. Ulus Travma Acil Cerrahi Derg. 2019 Mar;25(2):177-182. doi: 10.14744/tjtes.2019.70679.
PMID: 30892679
citation: Park JS, Kim JS, Kim YJ, Kim WY. Utility of the immature granulocyte percentage for diagnosing acute appendicitis among clinically suspected appendicitis in adult. J Clin Lab Anal. 2018 Sep;32(7):e22458. doi: 10.1002/jcla.22458. Epub 2018 Apr 30.
PMID: 29708633
citation: Kirkil C, Karabulut K, Aygen E, Ilhan YS, Yur M, Binnetoglu K, Bulbuller N. Appendicitis scores may be useful in reducing the costs of treatment for right lower quadrant pain. Ulus Travma Acil Cerrahi Derg. 2013 Jan;19(1):13-9. doi: 10.5505/tjtes.2013.88714.
PMID: 23588973
responsible party type: Principal Investigator
investigator affiliation: Kahramanmaras Sutcu Imam University
investigator full name: Mehmet Buğra Bozan
investigator title: Professor, Assistant
mesh term: Appendicitis
mesh term: Peritonitis
mesh term: Emergencies
mesh term: Acute Disease
mesh term: Metronidazole
sharing ipd: No