Appendicitis AcuteNCT04791657
Outcome of Elderly Patients With Appendicitis
An observational study of Appendicitis Acute, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate factors that predict 30-day complications after the surgical treatment of appendicitis in elderly patients. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Appendicitis Acute
- What is being tested?
- Appendectomy
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: All patients aged 65 years and older undergoing appendectomy for acute appendicitis are included in this study
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gulhane Training and Research Hospital
Ankara, 06010
About this study
Official title: Factors Associated With Postoperative Complications After the Surgical Treatment of Appendicitis in Elderly Patients
This study aims to evaluate factors that predict 30-day complications after the surgical treatment of appendicitis in elderly patients.
Read the 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.
- Conditions
- Appendicitis Acute
- Being tested
- Appendectomy
- Keywords
- appendicitis, geriatrics
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AppendectomyProcedure or surgery
Surgical treatment for appendicitis
| Study group | Role | What they receive |
|---|---|---|
| Patients without complications | Patients with uneventful recovery Receives: Procedure: Appendectomy | |
| Patients with complications | Patients experiencing complications within 30 days postoperatively Receives: Procedure: Appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (2)
In-hospital mortality rate
In-hospital mortality is defined as death occurring during the hospital stay after the surgical procedure
Measured: 30 days
30-day readmission rate
30-day readmission is defined as unplanned readmission to the hospital within 30 days of discharge.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Jan 2017
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Suleyman Utku Celik, Gulhane Training and Research Hospital
- Investigators
- Suleyman U Celik, MD, Principal investigator, Gulhane Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04791657
- Sponsor's protocol ID
- Gulhane2021-51
- Status last verified
- Mar 2021
- First submitted
- 7 Mar 2021
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share IPD
Publications
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.
PubMed 32865733Yang 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.
PubMed 28708770Hui 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.
PubMed 12215147Pokharel 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.
PubMed 23016482
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Postoperative Complications After the Surgical Treatment of Appendicitis in Elderly Patients
- ClinicalTrials.gov ID
- NCT04791657
- Acronym / sponsor ID
- Gulhane2021-51
- Conditions
- Appendicitis Acute
- Keywords
- appendicitis, geriatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Gulhane Training and Research HospitalOther government
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate factors that predict 30-day complications after the surgical treatment of appendicitis in elderly patients.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without complications | – | Procedure: AppendectomyPatients with uneventful recovery |
| Patients with complications | – | Procedure: AppendectomyPatients experiencing complications within 30 days postoperatively |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All patients aged 65 years and older undergoing appendectomy for acute appendicitis are included in this study
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AppendectomySurgical treatment for appendicitis | Procedure or surgery | Patients with complications, Patients without complications |
Primary outcome
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
2 secondary outcomes
In-hospital mortality rate
Time frame: 30 days
30-day readmission rate
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Background: PubMed 32865733Angeramo 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.
- Background: PubMed 28708770Yang 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.
- Background: PubMed 12215147Hui 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.
- Background: PubMed 23016482Pokharel 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.
- Individual participant dataSharing planned: No. There is no plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suleyman U Celik, MD principal investigator
Gulhane Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Appendicitis Acute, run by Gulhane Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day postoperative complication rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04791657, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.