Inguinal HerniaNCT03450811
Effect of Inguinal Hernia Repair on Uroflowmetric Parameteres
A study testing Inguinal hernia repair in people with Inguinal Hernia and Urinary Retention, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Post operative acute urinary retension or voiding dysfunction are complications after inguinal hernia repair and they cause a great deal of discomfort and stress to patients. Furthermore, they can also increase hospital costs by increasing hospital stay, and by growing the need for outpatient appointments after an… Read more about this study
- Who is it for?
- Ages 20 to 90 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia, Urinary Retention, Lower Urinary Tract Symptoms
- What is being tested?
- Inguinal hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Mar 2018
- Phase
- Interventional
- 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 20 to 90 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- any type of inguinal hernia
Who cannot join
- active urinary tract infection,
- previous BPH, neurological disease or significant systemic disease,
- medications that could interfere voiding function
- history of prostate, bladder or urethral surgery or traumatic urethral catheterisation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, 06340
About this study
Official title: Does the Inguinal Hernia Repair Affect Uroflowmetric Values? A Prospective Controlled Clinical Trial.
Post operative acute urinary retension or voiding dysfunction are complications after inguinal hernia repair and they cause a great deal of discomfort and stress to patients. Furthermore, they can also increase hospital costs by increasing hospital stay, and by growing the need for outpatient appointments after an elective surgical procedure. Some studies recommend prophylactic alpha blockers to minimizing these adverse effects.
Investigators aimed to determine the changes of uroflowmetric values for male patients following elective inguinal hernia repair.
Read the detailed description
Inguinal hernia repair is a common procedure performed in general surgery, with an annual rate of 28 per 100,000 of the population in the USA. The incidence of post operative inability voiding in males following open or laparoscopic inguinal hernia repair varies from 3 to 25%. Evaluating risk factors to reduce the occurence of this complications after one of the most commonly performed surgery by general surgeons could help reduce that high rate of that complication. Although some authors recommend prophylactic alpha blockers, there is no consensus on whether these can decrease rate of urinary retention or voiding dysfunction in male patients.
In current study, investigators aimed to determinate the uroflowmetric parametric changes of patients after elective inguinal hernia repair.
- Being tested
- Inguinal hernia repair
- Keywords
- complication, uroflowmetry
- Medical subject headings
- Hernia, Inguinal, Urinary Retention, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inguinal hernia repairProcedure or surgery
Lichtenstein procedure or laparoscopic method (Total extraperitoneal) inguinal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | The patients underwent elective open or laparoscopic inguinal hernia repair at a general surgery clinic. Receives: Procedure: Inguinal hernia repair |
| Control group | No intervention | patients who were admitted to the outpatient clinics with various diseases or healthy persons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with undergoes inguinal hernia repair -related voiding dysfunction as assessed by uroflowmetry
Maximum and average flow rate (ml/sn) were determinated on post-operative day 1
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Jan 2018
- Primary completion20 Feb 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The patients who underwent elective open or laparoscopic inguinal hernia repair were treated by a single general surgeon.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Turkey
- Responsible party
- Principal investigator, Muhammet Fatih Kilinc, Ankara Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450811
- Sponsor's protocol ID
- 317
- Status last verified
- Mar 2018
- First submitted
- 19 Feb 2018
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mohammadi-Fallah M, Hamedanchi S, Tayyebi-Azar A. Preventive effect of tamsulosin on postoperative urinary retention. Korean J Urol. 2012 Jun;53(6):419-23. doi: 10.4111/kju.2012.53.6.419. Epub 2012 Jun 19.
PubMed 22741052Clancy C, Coffey JC, O'Riordain MG, Burke JP. A meta-analysis of the efficacy of prophylactic alpha-blockade for the prevention of urinary retention following primary unilateral inguinal hernia repair. Am J Surg. 2018 Aug;216(2):337-341. doi: 10.1016/j.amjsurg.2017.02.017. Epub 2017 Mar 14.
PubMed 28341140
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Inguinal Hernia Repair Affect Uroflowmetric Values? A Prospective Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT03450811
- Acronym / sponsor ID
- 317
- Keywords
- complication, uroflowmetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, Turkey
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 1 Mar 2018 (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.
Post operative acute urinary retension or voiding dysfunction are complications after inguinal hernia repair and they cause a great deal of discomfort and stress to patients. Furthermore, they can also increase hospital costs by increasing hospital stay, and by growing the need for outpatient appointments after an elective surgical procedure. Some studies recommend prophylactic alpha blockers to minimizing these adverse effects.
Investigators aimed to determine the changes of uroflowmetric values for male patients following elective inguinal hernia repair.
Detailed description
Inguinal hernia repair is a common procedure performed in general surgery, with an annual rate of 28 per 100,000 of the population in the USA. The incidence of post operative inability voiding in males following open or laparoscopic inguinal hernia repair varies from 3 to 25%. Evaluating risk factors to reduce the occurence of this complications after one of the most commonly performed surgery by general surgeons could help reduce that high rate of that complication. Although some authors recommend prophylactic alpha blockers, there is no consensus on whether these can decrease rate of urinary retention or voiding dysfunction in male patients.
In current study, investigators aimed to determinate the uroflowmetric parametric changes of patients after elective inguinal hernia repair.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The patients who underwent elective open or laparoscopic inguinal hernia repair were treated by a single general surgeon.
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Procedure: Inguinal hernia repairThe patients underwent elective open or laparoscopic inguinal hernia repair at a general surgery clinic. |
| Control group | No intervention | –patients who were admitted to the outpatient clinics with various diseases or healthy persons |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any type of inguinal hernia
Key exclusion criteria (4 listed)
- active urinary tract infection,
- previous BPH, neurological disease or significant systemic disease,
- medications that could interfere voiding function
- history of prostate, bladder or urethral surgery or traumatic urethral catheterisation.
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 |
|---|---|---|
| Inguinal hernia repairLichtenstein procedure or laparoscopic method (Total extraperitoneal) inguinal hernia repair | Procedure or surgery | Study group |
Primary outcome
Number of participants with undergoes inguinal hernia repair -related voiding dysfunction as assessed by uroflowmetry
Time frame: 3 days
Maximum and average flow rate (ml/sn) were determinated on post-operative day 1
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 27 Mar 2018.
- Results publication: PubMed 22741052Mohammadi-Fallah M, Hamedanchi S, Tayyebi-Azar A. Preventive effect of tamsulosin on postoperative urinary retention. Korean J Urol. 2012 Jun;53(6):419-23. doi: 10.4111/kju.2012.53.6.419. Epub 2012 Jun 19.
- Results publication: PubMed 28341140Clancy C, Coffey JC, O'Riordain MG, Burke JP. A meta-analysis of the efficacy of prophylactic alpha-blockade for the prevention of urinary retention following primary unilateral inguinal hernia repair. Am J Surg. 2018 Aug;216(2):337-341. doi: 10.1016/j.amjsurg.2017.02.017. Epub 2017 Mar 14.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inguinal hernia repair in people with Inguinal Hernia and Urinary Retention, run by Ankara 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 1 inclusion and 4 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 27 Mar 2018. 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?
Number of participants with undergoes inguinal hernia repair -related voiding dysfunction as assessed by uroflowmetry (time frame: 3 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 NCT03450811, which also lists 2 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 27 Mar 2018.