search
Back to results

Preoperative Immature Granulocyte Count and Percentage for Acute Appendisitis

Primary Purpose

Acute Appendicitis

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Appendectomy
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Appendicitis focused on measuring Acute Appendicitis, Complicated Acute Appandicitis, Emergent Surgery, Immature Granulocyte Count, Immature Granulocyte Percentage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >18 years,
  • Patients diagnosed as acute appenditicitis cases according to clinical (preoperative and peroperative) and preoperative laboratory findings and imaging modalities (ultrasound, computed tomography), and pathologic results
  • Patients who were operated by the same surgical team of the Kahramanmaras Sutcu Imam University Hospital.

Exclusion Criteria:

  • Patients younger than 18 years,
  • Negative appendectomies according to peroperative findings and pathologic findins
  • Patients whose data were not available
  • Patients who were operated by the other surgical team of the Kahramanmaras Sutcu Imam University.

Sites / Locations

  • Kahramanmaraş Sütçü İmam University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Complicated Acute Appendicitis

Uncomplicated Acute Appendicitis

Arm Description

The patients were assigned to the complicated acute appendicitis group (Group C) based on the preoperative imaging findings (periappendiceal abscess formation or significant periappendiceal fat tissue contamination in ultrasonography and computed tomography), intraoperative exploration findings (presence of gangrenous appendicitis, perforation or abscess formation), and pathological examination findings (acute phlegmonous appendicitis, acute gangrenous appendicitis or acute perforated appendicitis).

The patients were assigned to the uncomplicated acute appendicitis group (Group UC) based on the increased diameter and wall thickness of the appendix and detection of minimal contamination in the surrounding fat tissue in the imaging tests; the presence of edema and the absence of gangrene, perforation or abscess in the the exploratory surgery of appendix, and confirmation of the diagnosis of acute appendicitis by the pathological examination findings

Outcomes

Primary Outcome Measures

Preoperative IG count of the patients to differentiate complicated and uncomplciated acute appendicitis
Preoperative IG count of the patients to differentiate complicated and uncomplciated acute appendicitis
Preoperative IG count for selection of medical treatment patients of noncomplicated acute appendicitis
Preoperative IG count of the patients to select medically treatment patients of noncomplicated acute appendicitis
Preoperative IG percentage of the patients to differentiate complicated and uncomplciated acute appendicitis
Preoperative IG percentage of the patients to differentiate complicated and uncomplciated acute appendicitis
Preoperative IG percentage for selection of medical treatment patients of noncomplicated acute appendicitis
Preoperative IG percentage of the patients to select medically treatment patients of noncomplicated acute appendicitis

Secondary Outcome Measures

Full Information

First Posted
June 17, 2020
Last Updated
October 13, 2023
Sponsor
Kahramanmaras Sutcu Imam University
search

1. Study Identification

Unique Protocol Identification Number
NCT04440150
Brief Title
Preoperative Immature Granulocyte Count and Percentage for Acute Appendisitis
Official Title
Preoperative Immature Granulocyte Count and Percentage for Complicated and Uncomplicated Appendisitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Appendectomy is the most effective treatment option for acute appendisitis, which is the most commen emergent surgical pathology. However with in time period, surgical treatment borders are narrowed. Especially in uncomplicated acute appendicitis cases, nonoperative management (NOM) with antibiotherapies becomes primary treatment option. The COVID-19 pandemic, which is caused by 2019 novel coronavirus (2019-nCoV) and we encountered in the current process, has led to the re-questioning of surgical elective and emergency cases. Serious complications and increased mortality rates of the 2019-nCoV creates a novel problems of patient selection for emergent surgery and health care workers faced with potential health problems. As the same as the other surgical procedures, in the uncomplicated acute appendisitis cases NOM become more mandantory. NOM of uncomplicated acute appendisitis doen't increase perforation risk and general practice for decreasing surgical complications in the COVID-19 pandemic period. Additionally complicated acute appendicitis accounts for 20 to 30% of the patients undergoing appendectomy and lead to increased risk of postoperative complications, delayed recovery and longer hospital stay. Therefore, early diagnosis of complicated acute appendicitis is important; however, the most appropriate and inexpensive diagnostic method to make this diagnosis has not been established yet. Although the use of imaging methods is widespread, these methods are not accessible in many rural hospitals due to the high costs and unavailability of specialists. Thus, the need for an inexpensive and effective diagnostic technique allowing to make a differential diagnosis has not been met yet. For this purpose, several inexpensive and easily accessible blood parameter tests have been proposed; including the white blood cell count, immature granulocyte (IG) percentage, C-reactive protein levels or the neutrophil-to-lymphocyte ratio. An increase in the IG count shows that the bone marrow is active. This parameter has been used as a prognostic factor in many infectious and non infectious diseases including sepsis, acute pancreatitis, and acute myocardial infarction. The Immature granulocyte (IG) fraction includes promyelocytes, myelocytes, and metamyelocytes but not band neutrophils or myeloblasts. The IG count and percentage has become an easy-to-use method, especially with the introduction of technological advances, as it can be easily determined using the results of a routine complete blood count. It is aimed to efficacy of IG count and percentage which are calculated automatically in CBC samples, to differatiate the complicated and uncomplicated acute appendicitis cases with a cheap, easily applicable and cost effective test, especially in rural areas without enough diagnostic tests in COVID-19 pandemy.
Detailed Description
The data of 146 patients elder than 18 years, who admitted to the Emergency Department and General Surgery outpatient clinic with the complaint of abdominal pain diagnosed with acute appendicitis and who were operated by the same surgical team between June 2018 and June 2019 were evaluated retrospectively after the approval of the local ethics committee. Patients' data were obtained by reviewing the patient follow charts, laboratory findings in the the electronic database of the hospital and epicrisis forms. Totally 76 patients excluded from the study; 22 patients were excluded because of the pathological diagnosis did not confirm acute appendicitis (negative appendectomies and appendiceal mucinous cystadenomas), 54 patients who were operated by the other surgical team were excluded. The patients were assigned to the complicated acute appendicitis group (Group C) based on the preoperative imaging findings (periappendiceal abscess formation or significant periappendiceal fat tissue contamination in ultrasonography and computed tomography), intraoperative exploration findings (presence of gangrenous appendicitis, perforation or abscess formation), and pathological examination findings (acute phlegmonous appendicitis, acute gangrenous appendicitis or acute perforated appendicitis). The patients were assigned to the uncomplicated acute appendicitis group (Group UC) based on the increased diameter and wall thickness of the appendix and detection of minimal contamination in the surrounding fat tissue in the imaging tests; the presence of edema and the absence of gangrene, perforation or abscess in the the exploratory surgery of appendix, and confirmation of the diagnosis of acute appendicitis by the pathological examination findings [17-20]. The WBC, IG count and IG percentage automatically calculated in the complete blood count (CBC) parameters. WBC count, neutrophil count, lymphocyte count, and IG% were measured using an automated hematological analyzer (XN 3000; Sysmex Corp., Kobe, Japan) from blood samples obtained at the initial admission to the emergency department . Neutrophyl and Lymphocyte counts were obtained from automatically from the CBC parameters and NLR was calculated manually. The demographic data (age, sex) of the patients, the white blood cell count (WBC), the neutrophil-to-lymphocyte ratio (NLR), and the IG count and percentage were evaluated retrospectively. Statistical Analysis Statistical analyses were performed with the IBM Statistical Package for Social Sciences (SPSS) version 20.0 software. The student t-test or Mann-Whitney U test were used for analyzing the quantitive values based on normality of the distrubution calculated with Shapiro Wilk Test. The chi-square test or Fischer's exact test was used for analyzing the categorical data. ROC analysis was used to determeine spesivity and sensitivity of the parameters. Binary logistic regression analysis was performed to determine the preoperative diagnostic accuracy of the parameters. The quantitive data were given mean ± standard deviation (minimum - maximum values) or median (minimum - maximum values). The qualitative values were given number of cases (n) and percentage (%). A p-value of <0.05 was considered statistically significant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Appendicitis
Keywords
Acute Appendicitis, Complicated Acute Appandicitis, Emergent Surgery, Immature Granulocyte Count, Immature Granulocyte Percentage

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Retrospective Cohort Study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Complicated Acute Appendicitis
Arm Type
Other
Arm Description
The patients were assigned to the complicated acute appendicitis group (Group C) based on the preoperative imaging findings (periappendiceal abscess formation or significant periappendiceal fat tissue contamination in ultrasonography and computed tomography), intraoperative exploration findings (presence of gangrenous appendicitis, perforation or abscess formation), and pathological examination findings (acute phlegmonous appendicitis, acute gangrenous appendicitis or acute perforated appendicitis).
Arm Title
Uncomplicated Acute Appendicitis
Arm Type
Other
Arm Description
The patients were assigned to the uncomplicated acute appendicitis group (Group UC) based on the increased diameter and wall thickness of the appendix and detection of minimal contamination in the surrounding fat tissue in the imaging tests; the presence of edema and the absence of gangrene, perforation or abscess in the the exploratory surgery of appendix, and confirmation of the diagnosis of acute appendicitis by the pathological examination findings
Intervention Type
Procedure
Intervention Name(s)
Appendectomy
Intervention Description
Open or Laparascopic Surgery
Primary Outcome Measure Information:
Title
Preoperative IG count of the patients to differentiate complicated and uncomplciated acute appendicitis
Description
Preoperative IG count of the patients to differentiate complicated and uncomplciated acute appendicitis
Time Frame
Preoperative
Title
Preoperative IG count for selection of medical treatment patients of noncomplicated acute appendicitis
Description
Preoperative IG count of the patients to select medically treatment patients of noncomplicated acute appendicitis
Time Frame
Preoperative
Title
Preoperative IG percentage of the patients to differentiate complicated and uncomplciated acute appendicitis
Description
Preoperative IG percentage of the patients to differentiate complicated and uncomplciated acute appendicitis
Time Frame
Preoperative
Title
Preoperative IG percentage for selection of medical treatment patients of noncomplicated acute appendicitis
Description
Preoperative IG percentage of the patients to select medically treatment patients of noncomplicated acute appendicitis
Time Frame
Preoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18 years, Patients diagnosed as acute appenditicitis cases according to clinical (preoperative and peroperative) and preoperative laboratory findings and imaging modalities (ultrasound, computed tomography), and pathologic results Patients who were operated by the same surgical team of the Kahramanmaras Sutcu Imam University Hospital. Exclusion Criteria: Patients younger than 18 years, Negative appendectomies according to peroperative findings and pathologic findins Patients whose data were not available Patients who were operated by the other surgical team of the Kahramanmaras Sutcu Imam University.
Facility Information:
Facility Name
Kahramanmaraş Sütçü İmam University
City
Kahramanmaraş
ZIP/Postal Code
46000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25254521
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.
Results Reference
background
PubMed Identifier
32394416
Citation
Gok AFK, Eryilmaz M, Ozmen MM, Alimoglu O, Ertekin C, Kurtoglu MH. Recommendations for Trauma and Emergency General Surgery Practice During COVID-19 Pandemic. Ulus Travma Acil Cerrahi Derg. 2020 Apr;26(3):335-342. doi: 10.14744/tjtes.2020.79954.
Results Reference
background
PubMed Identifier
32329524
Citation
Hogan A. COVID-19 and emergency surgery. Br J Surg. 2020 Jun;107(7):e180. doi: 10.1002/bjs.11640. Epub 2020 Apr 24. No abstract available.
Results Reference
background
PubMed Identifier
32352836
Citation
De Simone B, Chouillard E, Di Saverio S, Pagani L, Sartelli M, Biffl WL, Coccolini F, Pieri A, Khan M, Borzellino G, Campanile FC, Ansaloni L, Catena F. Emergency surgery during the COVID-19 pandemic: what you need to know for practice. Ann R Coll Surg Engl. 2020 May;102(5):323-332. doi: 10.1308/rcsann.2020.0097. Epub 2020 Apr 30.
Results Reference
background
PubMed Identifier
32362368
Citation
Collard M, Lakkis Z, Loriau J, Mege D, Sabbagh C, Lefevre JH, Maggiori L. Antibiotics alone as an alternative to appendectomy for uncomplicated acute appendicitis in adults: Changes in treatment modalities related to the COVID-19 health crisis. J Visc Surg. 2020 Jun;157(3S1):S33-S42. doi: 10.1016/j.jviscsurg.2020.04.014. Epub 2020 Apr 24.
Results Reference
background
PubMed Identifier
32403188
Citation
Kelly ME, Murphy E, Bolger JC, Cahill RA. COVID-19 and the treatment of acute appendicitis in Ireland: a new era or short-term pivot? Colorectal Dis. 2020 Jun;22(6):648-649. doi: 10.1111/codi.15141. Epub 2020 May 31. No abstract available.
Results Reference
background
PubMed Identifier
29426650
Citation
Diaz-Barrientos CZ, Aquino-Gonzalez A, Heredia-Montano M, Navarro-Tovar F, Pineda-Espinosa MA, Espinosa de Santillana IA. The RIPASA score for the diagnosis of acute appendicitis: A comparison with the modified Alvarado score. Rev Gastroenterol Mex (Engl Ed). 2018 Apr-Jun;83(2):112-116. doi: 10.1016/j.rgmx.2017.06.002. Epub 2018 Feb 6. English, Spanish.
Results Reference
background
PubMed Identifier
29708633
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.
Results Reference
background
PubMed Identifier
31363446
Citation
Khan MS, Siddiqui MTH, Shahzad N, Haider A, Chaudhry MBH, Alvi R. Factors Associated with Complicated Appendicitis: View from a Low-middle Income Country. Cureus. 2019 May 28;11(5):e4765. doi: 10.7759/cureus.4765.
Results Reference
background
PubMed Identifier
30871739
Citation
Hakkoymaz H, Nazik S, Seyithanoglu M, Guler O, Sahin AR, Cengiz E, Yazar FM. The value of ischemia-modified albumin and oxidative stress markers in the diagnosis of acute appendicitis in adults. Am J Emerg Med. 2019 Nov;37(11):2097-2101. doi: 10.1016/j.ajem.2019.03.005. Epub 2019 Mar 7.
Results Reference
background
PubMed Identifier
29581687
Citation
Yazar FM, Urfalioglu A, Bakacak M, Boran OF, Bulbuloglu E. Efficacy of the Evaluation of Inflammatory Markers for the Reduction of Negative Appendectomy Rates. Indian J Surg. 2018 Feb;80(1):61-67. doi: 10.1007/s12262-016-1558-y. Epub 2016 Oct 18.
Results Reference
background
PubMed Identifier
24798344
Citation
van der Geest PJ, Mohseni M, Brouwer R, van der Hoven B, Steyerberg EW, Groeneveld AB. Immature granulocytes predict microbial infection and its adverse sequelae in the intensive care unit. J Crit Care. 2014 Aug;29(4):523-7. doi: 10.1016/j.jcrc.2014.03.033. Epub 2014 Apr 5.
Results Reference
background
PubMed Identifier
24795281
Citation
Sauneuf B, Bouffard C, Cornet E, Daubin C, Desmeulles I, Masson R, Seguin A, Valette X, Terzi N, Parienti JJ, du Cheyron D. Immature/total granulocyte ratio: a promising tool to assess the severity and the outcome of post-cardiac arrest syndrome. Resuscitation. 2014 Aug;85(8):1115-9. doi: 10.1016/j.resuscitation.2014.04.017. Epub 2014 Apr 30.
Results Reference
background
PubMed Identifier
30394497
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.
Results Reference
background
PubMed Identifier
30806482
Citation
Ayres LS, Sgnaolin V, Munhoz TP. Immature granulocytes index as early marker of sepsis. Int J Lab Hematol. 2019 Jun;41(3):392-396. doi: 10.1111/ijlh.12990. Epub 2019 Feb 26.
Results Reference
background
PubMed Identifier
30985959
Citation
Soh JS, Lim SW. Delta neutrophil index as a prognostic marker in emergent abdominal surgery. J Clin Lab Anal. 2019 Jul;33(6):e22895. doi: 10.1002/jcla.22895. Epub 2019 Apr 15.
Results Reference
background
PubMed Identifier
30949783
Citation
Jha P, Espinoza N, Webb E, Kohli M, Poder L, Morgan T. Single institutional experience with initial ultrasound followed by computed tomography or magnetic resonance imaging for acute appendicitis in adults. Abdom Radiol (NY). 2019 Jul;44(7):2357-2365. doi: 10.1007/s00261-019-01998-1.
Results Reference
background
PubMed Identifier
31414891
Citation
Kim HY, Park JH, Lee SS, Lee WJ, Ko Y, Andersson RE, Lee KH. CT in Differentiating Complicated From Uncomplicated Appendicitis: Presence of Any of 10 CT Features Versus Radiologists' Gestalt Assessment. AJR Am J Roentgenol. 2019 Nov;213(5):W218-W227. doi: 10.2214/AJR.19.21331. Epub 2019 Aug 15.
Results Reference
background
PubMed Identifier
31112397
Citation
Rawolle T, Reismann M, Minderjahn MI, Bassir C, Hauptmann K, Rothe K, Reismann J. Sonographic differentiation of complicated from uncomplicated appendicitis. Br J Radiol. 2019 Jul;92(1099):20190102. doi: 10.1259/bjr.20190102. Epub 2019 May 29.
Results Reference
background
PubMed Identifier
28039865
Citation
Xu Y, Jeffrey RB, Chang ST, DiMaio MA, Olcott EW. Sonographic Differentiation of Complicated From Uncomplicated Appendicitis: Implications for Antibiotics-First Therapy. J Ultrasound Med. 2017 Feb;36(2):269-277. doi: 10.7863/ultra.16.03109. Epub 2016 Dec 31.
Results Reference
background

Learn more about this trial

Preoperative Immature Granulocyte Count and Percentage for Acute Appendisitis

We'll reach out to this number within 24 hrs