Immature Granulocyte [IG] Count and Percentage for Medical Treatment of Uncomplicated Acute Appendicitis

NCT04462588 | Completed DMC

• 1 other identifier: 179
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Appendicitis Without Peritonitis; Medical Emergencies

Keywords

Uncomplicated Acute Appendisitis; Alvarado Scoring System; Immature Granulocyte Count; Immature Granulocyte Percentage

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Medical treatment continue

  Started with administration to the clinic and finished with the 24th hour of the follow up

• Medical treatment continue

  Started with administration to the clinic and finished with the 24th hour of the follow up

• Medical treatment continue

  ALVARADO Score in the first administration to the clinic and the 24th hour of the follow up

Study Arms (2)

Medical Treatment Group

Medical treatment group of uncomplicated acute appendisitis

Drug: Cipro 400 MG in 200 ML Injection; Drug: Flagyl I.V. RTU

Surgery

Operated group of uncomplicated acute appendisitis

Procedure: appendectomy (open or laparascopic)

Interventions

Cipro 400 MG in 200 ML Injection DRUG

medical tratment group

Also known as: Medical treatment of acute appendicitis

Medical Treatment Group

Flagyl I.V. RTU DRUG

medical tratment group

Also known as: Medical treatment of acute appendicitis

Medical Treatment Group

appendectomy (open or laparascopic) PROCEDURE

appendectomy (open or laparascopic)

Also known as: Appendectomy

Surgery

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Elder than 18 years old
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Uncomplicated acute appendicitis cases

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Study Sites (1)

Kahramanmaraş Sütçü İmam University

Kahramanmaraş, 46000, Turkey (Türkiye)

Location

Related Publications (12)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 30264120 BACKGROUND

• 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 BACKGROUND

• Wojciechowicz KH, Hoffkamp HJ, van Hulst RA. Conservative treatment of acute appendicitis: an overview. Int Marit Health. 2010;62(4):265-72.

  PMID: 21348022 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

Ciprofloxacin; Injections; Appendectomy

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Assistant

Study Record Dates

• First Submitted: June 27, 2020
• First Posted: July 8, 2020
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: October 17, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)