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Outcome of Elderly Patients With Appendicitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04791657
Recruitment Status : Completed
First Posted : March 10, 2021
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Suleyman Utku Celik, Gulhane Training and Research Hospital

Study Description
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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
Appendicitis Acute 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
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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 : January 1, 2017
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. 30-day postoperative complication rate [ Time Frame: 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 [ Time Frame: 30 days ]
    In-hospital mortality is defined as death occurring during the hospital stay after the surgical procedure

  2. 30-day readmission rate [ Time Frame: 30 days ]
    30-day readmission is defined as unplanned readmission to the hospital within 30 days of discharge.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients aged 65 years and older undergoing appendectomy for acute appendicitis are included in this study
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04791657


Locations
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Turkey
Gulhane Training and Research Hospital
Ankara, Turkey, 06010
Sponsors and Collaborators
Gulhane Training and Research Hospital
Investigators
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Principal Investigator: Suleyman U Celik, MD Gulhane Training and Research Hospital
More Information
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Publications:

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Responsible Party: Suleyman Utku Celik, Principal Investigator, Gulhane Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04791657    
Other Study ID Numbers: Gulhane2021-51
First Posted: March 10, 2021    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suleyman Utku Celik, Gulhane Training and Research Hospital:
appendicitis
geriatrics
Additional relevant MeSH terms:
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Appendicitis
Intraabdominal Infections
Infections
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Cecal Diseases
Intestinal Diseases