Acute AppendicitisNCT04440150
Preoperative Immature Granulocyte Count and Percentage for Acute Appendisitis
A study testing Appendectomy in people with Acute Appendicitis, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Appendicitis
- What is being tested?
- Appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam University
Kahramanmaraş, 46000
About this study
Official title: Preoperative Immature Granulocyte Count and Percentage for Complicated and Uncomplicated Appendisitis
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.
Read the 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.
- Conditions
- Acute Appendicitis
- Being tested
- Appendectomy
- Keywords
- Acute Appendicitis, Complicated Acute Appandicitis, Emergent Surgery, Immature Granulocyte Count, Immature Granulocyte Percentage
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppendectomyProcedure or surgery
Open or Laparascopic Surgery
| Study group | Role | What they receive |
|---|---|---|
| Complicated Acute Appendicitis | Other | 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). Receives: Procedure: Appendectomy |
| Uncomplicated Acute Appendicitis | Other | 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 Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Preoperative
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
Measured: Preoperative
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
Measured: Preoperative
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
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Jun 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Acute AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Retrospective Cohort Study
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Buğra Bozan, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440150
- Sponsor's protocol ID
- 180
- Status last verified
- Oct 2023
- First submitted
- 17 Jun 2020
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25254521Gok 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.
PubMed 32394416Hogan 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.
PubMed 32329524De 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.
PubMed 32352836Collard 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.
PubMed 32362368Kelly 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.
PubMed 32403188Diaz-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.
PubMed 29426650Park 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.
PubMed 29708633Khan 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.
PubMed 31363446Hakkoymaz 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.
PubMed 30871739Yazar 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.
PubMed 29581687van 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.
PubMed 24798344Sauneuf 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.
PubMed 24795281Unal 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.
PubMed 30394497Ayres 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.
PubMed 30806482
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Immature Granulocyte Count and Percentage for Complicated and Uncomplicated Appendisitis
- ClinicalTrials.gov ID
- NCT04440150
- Acronym / sponsor ID
- 180
- Conditions
- Acute Appendicitis
- Keywords
- Acute Appendicitis, Complicated Acute Appandicitis, Emergent Surgery, Immature Granulocyte Count, Immature Granulocyte Percentage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Retrospective Cohort Study
| Arm | Type | Receives |
|---|---|---|
| Complicated Acute Appendicitis | Other | Procedure: AppendectomyThe 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). |
| Uncomplicated Acute Appendicitis | Other | Procedure: AppendectomyThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AppendectomyOpen or Laparascopic Surgery | Procedure or surgery | Complicated Acute Appendicitis, Uncomplicated Acute Appendicitis |
Primary outcome
Preoperative IG count of the patients to differentiate complicated and uncomplciated acute appendicitis
Time frame: Preoperative
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
Time frame: Preoperative
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
Time frame: Preoperative
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
Time frame: Preoperative
Preoperative IG percentage of the patients to select medically treatment patients of noncomplicated acute appendicitis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Background: PubMed 25254521Kirkil 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.
- Background: PubMed 32394416Gok 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.
- Background: PubMed 32329524Hogan 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.
- Background: PubMed 32352836De 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.
- Background: PubMed 32362368Collard 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.
- Background: PubMed 32403188Kelly 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.
- Background: PubMed 29426650Diaz-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.
- Background: PubMed 29708633Park 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.
- Background: PubMed 31363446Khan 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.
- Background: PubMed 30871739Hakkoymaz 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.
- Background: PubMed 29581687Yazar 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.
- Background: PubMed 24798344van 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appendectomy in people with Acute Appendicitis, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative IG count of the patients to differentiate complicated and uncomplciated acute appendicitis (time frame: Preoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04440150, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.