Inguinal HerniaNCT02418078
Retrospective Analysis of the Geriatric Patients Underwent Unilateral Inguinal Herniorrhaphy
An observational study of Inguinal Hernia, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- local infiltration anesthesia and sedation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 370 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2015to Mar 2015
- 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 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with a unilateral inguinal hernia
Who may be able to join
- patients with a unilateral inguinal hernia undergoing herniorrhaphy
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Inguinal Hernia
- Being tested
- local infiltration anesthesia and sedation
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local infiltration anesthesia and sedationProcedure or surgery
Also called local anesthesia and sedation
the surgical site is infiltrated with local anesthetic agents and the patients are sedated with intravenous agents
| Study group | Role | What they receive |
|---|---|---|
| Geriatri | patients ageing ≥ 65 yr undergoing herniorrhaphy with local infiltration anesthesia and sedation Receives: Procedure: local infiltration anesthesia and sedation | |
| non-geriatri | patients ageing 19-64 yr undergoing herniorrhaphy with local infiltration anesthesia and sedation Receives: Procedure: local infiltration anesthesia and sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
discharge time
Measured: postoperative 2 hours
discharge delay
Measured: postoperative 2 hours
local anesthetic doses
Measured: intraoperative
sedative doses
Measured: intraoperative
Secondary outcomes (3)
complications (hypertension, tachycardia, bradycardia, hypotension, nausea, vomiting)
Measured: intraoperative
early morbidity
Measured: postoperative 2 hours
morbidity
Measured: postopative 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Inguinal HerniaStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DILEK YAZICIOGLU, Diskapi Teaching and Research Hospital
- Investigators
- Hakan Kulacoglu, Prof, Study director, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418078
- Sponsor's protocol ID
- Geriatri Hernia
- Status last verified
- Feb 2015
- First submitted
- 14 Feb 2015
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19239413Majholm 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.
PubMed 22335277Dallas 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.
PubMed 22726915
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Geriatric Patients Underwent Unilateral Inguinal Herniorrhaphy at Our Institution
- ClinicalTrials.gov ID
- NCT02418078
- Acronym / sponsor ID
- Geriatri Hernia
- Conditions
- Inguinal Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 Apr 2015 (estimated)
- 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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Geriatri | – | Procedure: local infiltration anesthesia and sedationpatients ageing ≥ 65 yr undergoing herniorrhaphy with local infiltration anesthesia and sedation |
| non-geriatri | – | Procedure: local infiltration anesthesia and sedationpatients ageing 19-64 yr undergoing herniorrhaphy with local infiltration anesthesia and sedation |
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with a unilateral inguinal hernia
Key inclusion criteria (1 listed)
- patients with a unilateral inguinal hernia undergoing herniorrhaphy
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| local infiltration anesthesia and sedationAlso: local anesthesia and sedationthe surgical site is infiltrated with local anesthetic agents and the patients are sedated with intravenous agents | Procedure or surgery | Geriatri, non-geriatri |
Primary outcome
discharge time
Time frame: postoperative 2 hours
discharge delay
Time frame: postoperative 2 hours
local anesthetic doses
Time frame: intraoperative
sedative doses
Time frame: intraoperative
3 secondary outcomes
complications (hypertension, tachycardia, bradycardia, hypotension, nausea, vomiting)
Time frame: intraoperative
early morbidity
Time frame: postoperative 2 hours
morbidity
Time frame: postopative 1 week
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 16 Apr 2015.
- Results publication: PubMed 19239413Mattila 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.
- Results publication: PubMed 22335277Majholm 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.
- Results publication: PubMed 22726915Dallas 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.
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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.
Hakan Kulacoglu, Prof study director
Diskapi Teaching 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 Inguinal Hernia, run by Diskapi Teaching 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 1 inclusion and 1 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 16 Apr 2015. 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?
discharge time (time frame: postoperative 2 hours). The study lists 4 primary outcomes in all. 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 NCT02418078, which also lists 3 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 16 Apr 2015.