Effect of Inguinal Hernia Repair on Uroflowmetric Parameteres

NCT ID: NCT03450811

Last Updated: 2018-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-03-01

Brief Summary

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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

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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.

Conditions

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Inguinal Hernia Urinary Retention Lower Urinary Tract Symptoms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The patients who underwent elective open or laparoscopic inguinal hernia repair were treated by a single general surgeon.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants
The control group consisted of volunteer participitants who were admitted to the outpatient clinics with various reasons or healthy persons

Study Groups

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Study group

The patients underwent elective open or laparoscopic inguinal hernia repair at a general surgery clinic.

Group Type ACTIVE_COMPARATOR

Inguinal hernia repair

Intervention Type PROCEDURE

Lichtenstein procedure or laparoscopic method (Total extraperitoneal) inguinal hernia repair

Control group

patients who were admitted to the outpatient clinics with various diseases or healthy persons

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Inguinal hernia repair

Lichtenstein procedure or laparoscopic method (Total extraperitoneal) inguinal hernia repair

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, Turkey

OTHER_GOV

Sponsor Role collaborator

Ankara Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Muhammet Fatih Kilinc

Principal investigator, Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 22741052 (View on PubMed)

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.

Reference Type RESULT
PMID: 28341140 (View on PubMed)

Other Identifiers

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317

Identifier Type: -

Identifier Source: org_study_id

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