NCT04791657

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
Last Updated

March 10, 2021

Status Verified

March 1, 2021

Enrollment Period

4 years

First QC Date

March 7, 2021

Last Update Submit

March 7, 2021

Conditions

Keywords

appendicitisgeriatrics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • In-hospital mortality rate

    30 days

  • 30-day readmission rate

    30 days

Study Arms (2)

Patients without complications

Patients with uneventful recovery

Procedure: Appendectomy

Patients with complications

Patients experiencing complications within 30 days postoperatively

Procedure: Appendectomy

Interventions

AppendectomyPROCEDURE

Surgical treatment for appendicitis

Patients with complicationsPatients without complications

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients aged 65 years and older undergoing appendectomy for acute appendicitis are included in this study

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

Related 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. No abstract available.

    PMID: 32865733BACKGROUND
  • 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.

    PMID: 28708770BACKGROUND
  • 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. doi: 10.1001/archsurg.137.9.995.

    PMID: 12215147BACKGROUND
  • 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.

    PMID: 23016482BACKGROUND

MeSH Terms

Conditions

Appendicitis

Interventions

Appendectomy

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Suleyman U Celik, MD

    Gulhane Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2021

First Posted

March 10, 2021

Study Start

January 1, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 10, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

There is no plan to share IPD

Locations