- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02418078
Retrospective Analysis of the Geriatric Patients Underwent Unilateral Inguinal Herniorrhaphy
April 12, 2015 updated by: DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
Retrospective Analysis of the Geriatric Patients Underwent Unilateral Inguinal Herniorrhaphy at Our Institution
The aim of this study is to compare the geriatric patients with the non-geriatrics undergoing outpatient unilateral herniorrhapy in terms of local anesthesia, sedation, recovery and early morbidity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A retrospective data analysis will be conducted and the patient records will be evaluated for patient characteristics local anesthesia, sedation, recovery and early morbidity.
Study Type
Observational
Enrollment (Actual)
370
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey
- Dıskapı TRH
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with a unilateral inguinal hernia
Description
Inclusion Criteria:
patients with a unilateral inguinal hernia undergoing herniorrhaphy
Exclusion Criteria:
none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Geriatri
patients ageing ≥ 65 yr undergoing herniorrhaphy with local infiltration anesthesia and sedation
|
the surgical site is infiltrated with local anesthetic agents and the patients are sedated with intravenous agents
Other Names:
|
|
non-geriatri
patients ageing 19-64 yr undergoing herniorrhaphy with local infiltration anesthesia and sedation
|
the surgical site is infiltrated with local anesthetic agents and the patients are sedated with intravenous agents
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
discharge time
Time Frame: postoperative 2 hours
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postoperative 2 hours
|
|
discharge delay
Time Frame: postoperative 2 hours
|
postoperative 2 hours
|
|
local anesthetic doses
Time Frame: intraoperative
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intraoperative
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|
sedative doses
Time Frame: intraoperative
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intraoperative
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
complications (hypertension, tachycardia, bradycardia, hypotension, nausea, vomiting)
Time Frame: intraoperative
|
intraoperative
|
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early morbidity
Time Frame: postoperative 2 hours
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postoperative 2 hours
|
|
morbidity
Time Frame: postopative 1 week
|
postopative 1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Hakan Kulacoglu, Prof, Diskapi Teaching and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mattila K, Hynynen M; Intensium Consortium Study Group. Day surgery in Finland: a prospective cohort study of 14 day-surgery units. Acta Anaesthesiol Scand. 2009 Apr;53(4):455-63. doi: 10.1111/j.1399-6576.2008.01895.x. Epub 2009 Feb 23.
- Majholm B, Engbaek J, Bartholdy J, Oerding H, Ahlburg P, Ulrik AM, Bill L, Langfrits CS, Moller AM. Is day surgery safe? A Danish multicentre study of morbidity after 57,709 day surgery procedures. Acta Anaesthesiol Scand. 2012 Mar;56(3):323-31. doi: 10.1111/j.1399-6576.2011.02631.x.
- Dallas KB, Froylich D, Choi JJ, Rosa JH, Lo C, Colon MJ, Telem DA, Divino CM. Laparoscopic versus open inguinal hernia repair in octogenarians: a follow-up study. Geriatr Gerontol Int. 2013 Apr;13(2):329-33. doi: 10.1111/j.1447-0594.2012.00902.x. Epub 2012 Jun 21.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
February 14, 2015
First Submitted That Met QC Criteria
April 12, 2015
First Posted (Estimate)
April 16, 2015
Study Record Updates
Last Update Posted (Estimate)
April 16, 2015
Last Update Submitted That Met QC Criteria
April 12, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Geriatri Hernia
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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