COMPARISON OF LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR AND LICHTENSTEIN HERNIA REPAIR

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: TEP; Procedure: Lichtenstein repair

• Registration Number: NCT03935503
• Lead Sponsor: Fatih Sultan Mehmet Training and Research Hospital

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.

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2018-01-01
• Study Completion: 2019-04-01
• Study First Submitted: 2019-04-21
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-01
• Last Update Submitted: 2019-05-01
• Study First Posted: 2019-05-02
• Last Update Posted: 2019-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

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

Exclusion Criteria

• Patients with previous abdominal and inguinal hernia surgery
• ASA 3-4
• Sexually inactive
• Emergency patients (Etrangule inguinal hernia)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total Extraperitoneal Repair	TEP	Laparoscopic Total Extraperitoneal (TEP) method was performed to repair 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.
Lichtenstein repair	Lichtenstein repair	Lichtenstein method was performed to repair 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.

Primary Outcome Measures

Name	Time	Method
Inguinal Region Discrimination Test ( DT)	UP TO 6 MONTHS	Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
Follicle Stimulating Hormone levels	UP TO 6 MONTHS	Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
DN4 Neuropathic Pain Survey	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	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	UP TO 6 MONTHS	Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
International Sexual Function Index (IFIF)	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	UP TO 6 MONTHS	Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
Visual Analog Pain Scale	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.
Beck Depression Scale	UP TO 6 MONTHS	Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
Uroflowmetry test for urination	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	UP TO 6 MONTHS	Patients were evaluated preoperatively, at 1 month and 6 months postoperatively

Trial Locations

Locations (1)

Fatih Sultan Mehmet Research and Training Hospital; 🇹🇷 Istanbul, Turkey