Effect of Inguinal Hernia Repair on Uroflowmetric Parameteres

March 24, 2018 updated by: Muhammet Fatih Kilinc, Ankara Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06340
        • Ankara Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Training and Research Hospital

Collaborators

Ministry of Health, Turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

February 20, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

February 19, 2018

First Submitted That Met QC Criteria

February 23, 2018

First Posted (Actual)

March 1, 2018

Study Record Updates

Last Update Posted (Actual)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 24, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lower Urinary Tract Symptoms

Clinical Trials on Inguinal hernia repair

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Suriname

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe