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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03450811
Other study ID # 317
Secondary ID
Status Completed
Phase N/A
First received February 19, 2018
Last updated March 24, 2018
Start date January 1, 2018
Est. completion date March 1, 2018

Study information

Verified date March 2018
Source Ankara Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date March 1, 2018
Est. primary completion date February 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 90 Years
Eligibility Inclusion Criteria:

- any type of inguinal hernia

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.

Study Design


Intervention

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

Locations

Country Name City State
Turkey Ankara Training and Research Hospital Ankara

Sponsors (2)

Lead Sponsor Collaborator
Ankara Training and Research Hospital Ministry of Health, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. 2017 Mar 14. pii: S0002-9610(17)30020-X. d — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 3 days
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