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CompletedNCT03450811Updated Mar 27, 2018

Effect of Inguinal Hernia Repair on Uroflowmetric Parameteres

An interventional study of Inguinal hernia repair in Inguinal Hernia, Urinary Retention and Lower Urinary Tract Symptoms, sponsored by Ankara Training and Research Hospital. Completed at 1 site in Turkey. Open to male participants aged 20 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-27.

Sponsored by Ankara Training and Research Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
20 Years to 90 Years
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 76 studies in Hernia, Inguinal with a site in Turkey — 13 open to participants now, 15 under way, none of them phase 3. Hernia, Inguinal · Turkey.

Enrollment
8th of 59
120 · median 80
Started
2018
with 2 others
No phase
51 of 76
12 open now
Registered
17th of 76
by date

Among the 76 studies in Hernia, Inguinal with a site in Turkey, this one is the 8th largest by enrollment of the 59 interventional ones, is one of 3 that started in 2018, is one of 51 with no phase, and was the 17th registered.

By phase

76 studies; the count open now beside each. This study's row is marked.

No phasethis study51 · 12 open
Observational17 · 1 open
Phase 47 · 0 open
Phase 31 · 0 open

By the year they started

First in 2009; this study’s year is marked. 3 started in 2018.

Size and results

Median enrollment 80 across the 59 interventional studies, 63 across the 17 observational. Of the 51 that completed or were terminated, 1 (2%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 76 studies in Hernia, Inguinal with a site in Turkey, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Inguinal Hernia
  • Urinary Retention
  • Lower Urinary Tract Symptoms

Keywords

  • complication
  • uroflowmetry
04

Who can participate

Ages eligible
20 Years to 90 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • any type of inguinal hernia

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Study group

    The patients underwent elective open or laparoscopic inguinal hernia repair at a general surgery clinic.

    Procedure: Inguinal hernia repair

  • No intervention
    Control group

    patients who were admitted to the outpatient clinics with various diseases or healthy persons

Interventions

  • ProcedureInguinal hernia repair

    Lichtenstein procedure or laparoscopic method (Total extraperitoneal) inguinal hernia repair

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 days

07

Study locations

1 site
  • Ankara Training and Research Hospital
    Ankara, 06340, Turkey
08

References and documents

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 22741052 ↗
  • Clancy 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Feb 2018, 1 month.

Of 177 non-industry interventional studies with no phase under Hernia, Inguinal, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's 1 month is below that.

Counting every sponsor, half of 186 studies reached it within 19 months; a quarter within 9 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 19, 2018
First posted
Mar 1, 2018
StartActual
Jan 1, 2018
Primary completionActual
Feb 20, 2018
CompletionActual
Mar 1, 2018
Last update
Mar 27, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 27, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03450811
Lead sponsor
Ankara Training and Research Hospital
Collaborators
Ministry of Health, Turkey
Responsible party
Muhammet Fatih Kilinc (Principal investigator, Medical doctor, Ankara Training and Research Hospital) — Principal investigator
First posted
Mar 1, 2018
Start date
Jan 1, 2018
Primary completion
Feb 20, 2018
Completion
Mar 1, 2018
Last update
Mar 27, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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