Effect of Inguinal Hernia Repair on Uroflowmetric Parameteres
Primary Purpose
Inguinal Hernia, Urinary Retention, Lower Urinary Tract Symptoms
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inguinal hernia repair
Sponsored by
About this trial
This is an interventional diagnostic trial for Inguinal Hernia focused on measuring complication, uroflowmetry
Eligibility Criteria
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.
Sites / Locations
- Ankara Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Study group
Control group
Arm Description
The patients underwent elective open or laparoscopic inguinal hernia repair at a general surgery clinic.
patients who were admitted to the outpatient clinics with various diseases or healthy persons
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03450811
First Posted
February 19, 2018
Last Updated
March 24, 2018
Sponsor
Ankara Training and Research Hospital
Collaborators
Ministry of Health, Turkey
1. Study Identification
Unique Protocol Identification Number
NCT03450811
Brief Title
Effect of Inguinal Hernia Repair on Uroflowmetric Parameteres
Official Title
Does the Inguinal Hernia Repair Affect Uroflowmetric Values? A Prospective Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
February 20, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Training and Research Hospital
Collaborators
Ministry of Health, Turkey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Urinary Retention, Lower Urinary Tract Symptoms
Keywords
complication, uroflowmetry
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients who underwent elective open or laparoscopic inguinal hernia repair were treated by a single general surgeon.
Masking
Participant
Masking Description
The control group consisted of volunteer participitants who were admitted to the outpatient clinics with various reasons or healthy persons
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Active Comparator
Arm Description
The patients underwent elective open or laparoscopic inguinal hernia repair at a general surgery clinic.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
patients who were admitted to the outpatient clinics with various diseases or healthy persons
Intervention Type
Procedure
Intervention Name(s)
Inguinal hernia repair
Intervention Description
Lichtenstein procedure or laparoscopic method (Total extraperitoneal) inguinal hernia repair
Primary Outcome Measure Information:
Title
Number of participants with undergoes inguinal hernia repair -related voiding dysfunction as assessed by uroflowmetry
Description
Maximum and average flow rate (ml/sn) were determinated on post-operative day 1
Time Frame
3 days
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male patients
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ankara Training and Research Hospital
City
Ankara
ZIP/Postal Code
06340
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22741052
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.
Results Reference
result
PubMed Identifier
28341140
Citation
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.
Results Reference
result
Learn more about this trial
Effect of Inguinal Hernia Repair on Uroflowmetric Parameteres
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