Effect of Inguinal Hernia Repair on Uroflowmetric Parameteres

NCT03450811 | Completed DMC

• 1 other identifier: 317
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia; Urinary Retention; Lower Urinary Tract Symptoms

Keywords

complication; uroflowmetry

Outcome Measures

Primary Outcomes (1)

• 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

  3 days

Study Arms (2)

Study group

ACTIVE COMPARATOR

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

Procedure: Inguinal hernia repair

Control group

NO INTERVENTION

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

Interventions

Inguinal hernia repair PROCEDURE

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

Study group

Eligibility Criteria

• Age: 20 Years - 90 Years
• Gender Eligibility Details: Male patients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any type of inguinal hernia

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Training and Research Hospital: lead
• Ministry of Health, Turkey: collaborator

Study Sites (1)

Ankara Training and Research Hospital

Ankara, 06340, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 22741052 RESULT

• 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.

  PMID: 28341140 RESULT

MeSH Terms

Conditions

Hernia, Inguinal; Urinary Retention; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The control group consisted of volunteer participitants who were admitted to the outpatient clinics with various reasons or healthy persons
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Medical doctor

Model Details: The patients who underwent elective open or laparoscopic inguinal hernia repair were treated by a single general surgeon.

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: March 1, 2018
• Study Start: January 1, 2018
• Primary Completion: February 20, 2018
• Study Completion: March 1, 2018
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

TU (1)