Medical Emergencies Clinical Trial
— [IG]Official title:
Are the Changes in Immature Granulocyte Count and Percentage Significant in the Decision to Continue Medical Treatment of Uncomplicated Acute Appendicitis Cases
NCT number | NCT04462588 |
Other study ID # | 179 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2019 |
Est. completion date | June 1, 2020 |
Verified date | October 2023 |
Source | Kahramanmaras Sutcu Imam University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | June 1, 2020 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Clinically diagnosed uncomplicated acute appendisitis cases Uncomplicated acute appendicitis cases who accepted the study protocol Successfully medical treated acute appendicitis Operated uncomplicated acute appendicitis cases - Exclusion Criteria: Clinically diagnosed complicated acute appendisitis cases Uncomplicated acute appendicitis cases who do not accept the study protocol Patients with any type of malignancy (appendix or other organ) Patients with rheumatologic disease or blood diseases - |
Country | Name | City | State |
---|---|---|---|
Turkey | Kahramanmaras Sütçü Imam University | Kahramanmaras |
Lead Sponsor | Collaborator |
---|---|
Kahramanmaras Sutcu Imam University |
Turkey,
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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation
Wojciechowicz KH, Hoffkamp HJ, van Hulst RA. Conservative treatment of acute appendicitis: an overview. Int Marit Health. 2010;62(4):265-72. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Medical treatment success | Defining medical treatment success with immature granulocyte count (/mm3) comparing with appendectomy group's samples | Started with administration to the clinic and finished with the 24th hour of the follow up | |
Primary | Medical treatment success | Defining medical treatment success with immature granulocyte percentage (immature granulocyte count/total white blood cell count x100) comparing with appendectomy group's samples | Started with administration to the clinic and finished with the 24th hour of the follow up | |
Secondary | Medical treatment continue | Defining medical treatment success with immature granulocyte count (/mm3) comparing with appendectomy group's samples | Started with administration to the clinic and finished with the 24th hour of the follow up | |
Secondary | Medical treatment continue | Defining medical treatment success with immature granulocyte percentage (immature granulocyte count/total white blood cell count x100) comparing with appendectomy group's samples | Started with administration to the clinic and finished with the 24th hour of the follow up | |
Secondary | Medical treatment continue | Defining medical treatment success with ALVARADO Score comparing with appendectomy group's samples for continuing the medical treatment options | ALVARADO Score in the first administration to the clinic and the 24th hour of the follow up |
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