Outcome of Elderly Patients With Appendicitis

Appendicitis Acute Clinical Trial

Official title:

Factors Associated With Postoperative Complications After the Surgical Treatment of Appendicitis in Elderly Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04791657
• Other study ID #: Gulhane2021-51
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2021
• Source: Gulhane Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate factors that predict 30-day complications after the surgical treatment of appendicitis in elderly patients.

Description:

Appendicitis in elderly patients is more challenging due to delayed presentation and higher comorbidities, which is associated with increased postoperative morbidity and mortality. In this study, we aim to investigate the factors that predict 30-day complications after the surgical treatment of appendicitis in elderly patients. Records of patients who underwent appendectomy for appendicitis will be extracted. The primary outcome is 30-day postoperative complications. Independent variables examined include demographics, comorbidities, preoperative laboratory values, pathological findings, and surgical features. Both univariate and multivariate regression will be performed to identify factors associated with postoperative complications.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 65 years and older
• Patients undergoing appendectomy for acute appendicitis (pathologically confirmed)
• Patients having complete records of clinical data and postoperative follow-up records

Exclusion Criteria:

• Patients younger than 65 years
• Patients undergoing an appendectomy as part of another major operation or those with appendiceal malignancy
• Patients who are treated nonoperatively for acute appendicitis

Related Conditions & MeSH terms

• Appendicitis
• Appendicitis Acute

Intervention

Procedure:
• Appendectomy
Surgical treatment for appendicitis

Locations

Country	Name	City	State
Turkey	Gulhane Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Angeramo CA, Dreifuss NH, Giacone J, Schlottmann F. Outcomes of Acute Appendicitis in Elderly Patients: a Single Center Analysis of 2000 Laparoscopic Appendectomies. J Gastrointest Surg. 2020 Dec;24(12):2859-2861. doi: 10.1007/s11605-020-04726-z. Epub 2020 Aug 31. — View Citation

Hui TT, Major KM, Avital I, Hiatt JR, Margulies DR. Outcome of elderly patients with appendicitis: effect of computed tomography and laparoscopy. Arch Surg. 2002 Sep;137(9):995-8; discussion 999-1000. — View Citation

Pokharel N, Sapkota P, Kc B, Rimal S, Thapa S, Shakya R. Acute appendicitis in elderly patients: a challenge for surgeons. Nepal Med Coll J. 2011 Dec;13(4):285-8. — View Citation

Yang J, Yu K, Li W, Si X, Zhang J, Wu W, Cao Y. Laparoscopic Appendectomy for Complicated Acute Appendicitis in the Elderly: A Single-center Experience. Surg Laparosc Endosc Percutan Tech. 2017 Oct;27(5):366-368. doi: 10.1097/SLE.0000000000000447. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day postoperative complication rate	The primary clinical outcome of interest is 30-day postoperative complications. The Clavien-Dindo classification will be used to grade postoperative outcomes and complications	30 days
Secondary	In-hospital mortality rate	In-hospital mortality is defined as death occurring during the hospital stay after the surgical procedure	30 days
Secondary	30-day readmission rate	30-day readmission is defined as unplanned readmission to the hospital within 30 days of discharge.	30 days