Effect of Inguinal Hernia Repair on Uroflowmetric Parameteres

Sponsor

Ankara Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03450811

Collaborator

Ministry of Health, Turkey (Other)

120

Enrollment

Location

Arms

1.9

Actual Duration (Months)

61.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inguinal Hernia Urinary Retention Lower Urinary Tract Symptoms	Procedure: Inguinal hernia repair	N/A

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

Study Type:

Interventional

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.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 :

Jan 1, 2018

Actual Primary Completion Date :

Feb 20, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

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

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

Primary Outcome Measures

Number of participants with undergoes inguinal hernia repair -related voiding dysfunction as assessed by uroflowmetry [3 days]
Maximum and average flow rate (ml/sn) were determinated on post-operative day 1

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Ankara Training and Research Hospital	Ankara		Turkey	06340

Sponsors and Collaborators

Ankara Training and Research Hospital
Ministry of Health, Turkey

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Muhammet Fatih Kilinc, Principal investigator, Medical doctor, Ankara Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT03450811

Other Study ID Numbers:

First Posted:

Mar 1, 2018

Last Update Posted:

Mar 27, 2018

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Muhammet Fatih Kilinc, Principal investigator, Medical doctor, Ankara Training and Research Hospital

complication

uroflowmetry

Additional relevant MeSH terms:

Urinary Retention

Hernia

Hernia, Inguinal

Lower Urinary Tract Symptoms

Study Results

No Results Posted as of Mar 27, 2018