Outcome of Elderly Patients With Appendicitis

Sponsor
Gulhane Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04791657
Collaborator
(none)
80
1
48
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Appendectomy

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Factors Associated With Postoperative Complications After the Surgical Treatment of Appendicitis in Elderly Patients
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Dec 31, 2020
Actual Study Completion Date :
Dec 31, 2020

Arms and Interventions

Arm Intervention/Treatment
Patients without complications

Patients with uneventful recovery

Procedure: Appendectomy
Surgical treatment for appendicitis

Patients with complications

Patients experiencing complications within 30 days postoperatively

Procedure: Appendectomy
Surgical treatment for appendicitis

Outcome Measures

Primary Outcome Measures

  1. 30-day postoperative complication rate [30 days]

    The primary clinical outcome of interest is 30-day postoperative complications. The Clavien-Dindo classification will be used to grade postoperative outcomes and complications

Secondary Outcome Measures

  1. In-hospital mortality rate [30 days]

    In-hospital mortality is defined as death occurring during the hospital stay after the surgical procedure

  2. 30-day readmission rate [30 days]

    30-day readmission is defined as unplanned readmission to the hospital within 30 days of discharge.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Gulhane Training and Research Hospital Ankara Turkey 06010

Sponsors and Collaborators

  • Gulhane Training and Research Hospital

Investigators

  • Principal Investigator: Suleyman U Celik, MD, Gulhane Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Suleyman Utku Celik, Principal Investigator, Gulhane Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04791657
Other Study ID Numbers:
  • Gulhane2021-51
First Posted:
Mar 10, 2021
Last Update Posted:
Mar 10, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Suleyman Utku Celik, Principal Investigator, Gulhane Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 10, 2021