Effect of Inguinal Hernia Repair on Uroflowmetric Parameteres

Inguinal Hernia Clinical Trial

Official title:

Does the Inguinal Hernia Repair Affect Uroflowmetric Values? A Prospective Controlled Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03450811
• Other study ID #: 317
• 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
• 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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Lower Urinary Tract Symptoms
• Urinary Retention

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