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Effect of Inguinal Hernia Repair on Uroflowmetric Parameteres

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03450811
Recruitment Status : Completed
First Posted : March 1, 2018
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
Ministry of Health, Turkey
Information provided by (Responsible Party):
Muhammet Fatih Kilinc, Ankara Training and Research Hospital

Study Description
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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.


Condition or disease Intervention/treatment Phase
Inguinal Hernia Urinary Retention Lower Urinary Tract Symptoms Procedure: Inguinal hernia repair Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients who underwent elective open or laparoscopic inguinal hernia repair were treated by a single general surgeon.
Masking: Single (Participant)
Masking Description: The control group consisted of volunteer participitants who were admitted to the outpatient clinics with various reasons or healthy persons
Primary Purpose: Diagnostic
Official Title: Does the Inguinal Hernia Repair Affect Uroflowmetric Values? A Prospective Controlled Clinical Trial.
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : February 20, 2018
Actual Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Study group
The patients underwent elective open or laparoscopic inguinal hernia repair at a general surgery clinic.
 Procedure: Inguinal hernia repair
Lichtenstein procedure or laparoscopic method (Total extraperitoneal) inguinal hernia repair
No Intervention: Control group
patients who were admitted to the outpatient clinics with various diseases or healthy persons


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male patients
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03450811


Locations
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Turkey
Ankara Training and Research Hospital
Ankara, Turkey, 06340
Sponsors and Collaborators
Ankara Training and Research Hospital
Ministry of Health, Turkey
More Information
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Publications of Results:

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Responsible Party: Muhammet Fatih Kilinc, Principal investigator, Medical doctor, Ankara Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03450811    
Other Study ID Numbers: 317
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Muhammet Fatih Kilinc, Ankara Training and Research Hospital:
complication
uroflowmetry
Additional relevant MeSH terms:
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Urinary Retention
Hernia
Hernia, Inguinal
Lower Urinary Tract Symptoms
Pathological Conditions, Anatomical
 Hernia, Abdominal
Urological Manifestations
Urination Disorders
Urologic Diseases