Skip to main content
Clinical Trials/NCT03935503
NCT03935503
Completed
Not Applicable

COMPARISON OF LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR AND LICHTENSTEIN HERNIA REPAIR FOR SEXUAL, SENSORY, LIFE QUALITY AND URINARY FUNCTIONS

Fatih Sultan Mehmet Training and Research Hospital1 site in 1 country42 target enrollmentJuly 1, 2017
ConditionsInguinal Hernia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inguinal Hernia
Sponsor
Fatih Sultan Mehmet Training and Research Hospital
Enrollment
42
Locations
1
Primary Endpoint
Inguinal Region Discrimination Test ( DT)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The superiority of laparoscopic inguinal hernia surgery over open surgery has been shown in many high patient-numbered studies with early return to work, less pain and good cosmetic results. The aim of this study is to determine the differences between two different methods in terms of sexual, sensory, quality of life and urinary results.

Detailed Description

Between July 2017 and January 2018, 42 sexually active male patients were randomized with Laparoscopic Total Extraperitoneal (TEP) method and Lichtenstein (LCH) method and repair of inguinal hernia. Patients were evaluated preoperatively, at 1 month and 6 months postoperatively, International Sexual Function Index (IFIF), International Prostatic Symptom Score, SF-36 Quality of Life Scale, Visual Analog Pain Scale, Beck Depression Scale, Inguinal Region Discrimination Test ( DT), DN4 Neuropathic Pain Survey, Uroflowmetry and FSH, LH, Total Testosterone levels were evaluated.

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
April 1, 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fatih Sultan Mehmet Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

ANIL ERGIN

Dr Anil ERGIN , General Surgery , Asistant doctor

Fatih Sultan Mehmet Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Unilateral inguinal hernia (diagnosed by physical examination or imaging)
  • Sexual Active
  • Male gender
  • aged between 18 and 65
  • EHS Classification (Primary, lateral or medial, 1 and 2)

Exclusion Criteria

  • Patients with previous abdominal and inguinal hernia surgery
  • Sexually inactive
  • Emergency patients (Etrangule inguinal hernia)

Outcomes

Primary Outcomes

Inguinal Region Discrimination Test ( DT)

Time Frame: UP TO 6 MONTHS

Patients were evaluated preoperatively, at 1 month and 6 months postoperatively

Follicle Stimulating Hormone levels

Time Frame: UP TO 6 MONTHS

Patients were evaluated preoperatively, at 1 month and 6 months postoperatively

Beck Depression Scale

Time Frame: UP TO 6 MONTHS

Patients were evaluated preoperatively, at 1 month and 6 months postoperatively

DN4 Neuropathic Pain Survey

Time Frame: UP TO 6 MONTHS

Patients were evaluated preoperatively, at 1 month and 6 months postoperatively. There are 4 questions in this survey and includes totally 10 points in it. Above the 4 points mean it is a neuropathic pain.

International Prostatic Symptom Score

Time Frame: UP TO 6 MONTHS

Patients were evaluated preoperatively, at 1 month and 6 months postoperatively. Total 7 questions which are about urinary functions are included.Answers are include 1-5 options. (1:never , 5:always) . Questions are : 1. what is your frequency of feeling that your bladder does not empty after urination 2. what is the frequency of needing to urinate in less than 2 hours after urination? 3. what is your frequency of stopping several times when you urinate and restart? 4. how often do you have difficulty urinating? 5. how often did you feel the reduction in the power of your urine? 6. how often have you experienced difficulty urinating? 7. how many times have you gone to urinate until you get up in the morning?

Total Testosterone levels

Time Frame: UP TO 6 MONTHS

Patients were evaluated preoperatively, at 1 month and 6 months postoperatively

International Sexual Function Index (IFIF)

Time Frame: UP TO 6 MONTHS

Patients were evaluated preoperatively, at 1 month and 6 months postoperatively.Total 15 questions are included.Answers are include 1-5 options. (1:never , 5:always) Question 1,2,3,4,5,15 for erectile function , Question 9,10 for orgasm function , Question 11,12 for sexual desire , Question 6,7,8 for sexual satisfaction , Question 13,14 for general satisfaction.

SF-36 Quality of Life Scale

Time Frame: UP TO 6 MONTHS

Patients were evaluated preoperatively, at 1 month and 6 months postoperatively

Visual Analog Pain Scale

Time Frame: UP TO 6 MONTHS

Patients were evaluated preoperatively, at 1 month and 6 months postoperatively.pain scores (VAS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.

Uroflowmetry test for urination

Time Frame: UP TO 6 MONTHS

In our study, the evaluation of urinary functions was performed with urolowmetry. Patients were evaluated preoperatively, at 1 month and 6 months postoperatively Voiding flow rates and voiding volumes were compared before and after surgery with Uroflowmetry

Luteinising Hormone levels

Time Frame: UP TO 6 MONTHS

Patients were evaluated preoperatively, at 1 month and 6 months postoperatively

Study Sites (1)

Loading locations...

Similar Trials