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COMPARISON OF LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR AND LICHTENSTEIN HERNIA REPAIR (HERNIA)

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ClinicalTrials.gov Identifier: NCT03935503
Recruitment Status : Completed
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
ANIL ERGIN, 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.

Condition or disease Intervention/treatment
Inguinal Hernia Procedure: TEP Procedure: Lichtenstein repair

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 42 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: COMPARISON OF LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR AND LICHTENSTEIN HERNIA REPAIR FOR SEXUAL, SENSORY, LIFE QUALITY AND URINARY FUNCTIONS
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : January 1, 2018
Actual Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Group/Cohort Intervention/treatment
Total Extraperitoneal Repair
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.
Procedure: TEP
By making a 2 cm incision under the umbilicus, skin subcutaneous tissues are passed through blunt dissections and the anterior fascia of the rectus muscle is exposed. An anterior rectus sheath with a scalpel is performed with a 15 mm incision. The rectus muscle is laterally lateralized and the balloon trocar or laparoscope itself is advanced from the midline to the symphysis pubis via the posterior rectus sheath. After the peritoneal cavity is dissected, a low pressure pneumoperitone 10 mm Hasson trocar or another 10 mm balloon caged trocar is advanced through the subumblic incision. 9-11 mmHg low pressure pneumoperitoneum is created to prevent the development of subcutaneous emphysema. For proper imaging, the patient should have complete muscle relaxation. The patient is given a position towards the light trandelenburg and non-hernia side.

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.
Procedure: Lichtenstein repair

After the inguinal incision, the skin and subcutaneous camper and scarpa tissues are passed and the external oblique aponeurosis is dissected in the direction of the extension of the fibers and the medial lateral edge of the rectus is dissected to the lateral inguinal ligament, then the spermatic cord is released and suspended.The spermatic cord is separated from the inguinal canal.

In indirect hernias, the hernia sac is dissected from the spermatic cord and rejected into the abdomen by high ligation. In direct hernia, the hernia sac is pushed in and the transverse fascia is sutured with 2-3 separe stitches.





Primary Outcome Measures :
  1. 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.

  2. 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?

  3. SF-36 Quality of Life Scale [ Time Frame: UP TO 6 MONTHS ]
    Patients were evaluated preoperatively, at 1 month and 6 months postoperatively

  4. 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.

  5. Beck Depression Scale [ Time Frame: UP TO 6 MONTHS ]
    Patients were evaluated preoperatively, at 1 month and 6 months postoperatively

  6. Inguinal Region Discrimination Test ( DT) [ Time Frame: UP TO 6 MONTHS ]
    Patients were evaluated preoperatively, at 1 month and 6 months postoperatively

  7. 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.

  8. 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

  9. Follicle Stimulating Hormone levels [ Time Frame: UP TO 6 MONTHS ]
    Patients were evaluated preoperatively, at 1 month and 6 months postoperatively

  10. Luteinising Hormone levels [ Time Frame: UP TO 6 MONTHS ]
    Patients were evaluated preoperatively, at 1 month and 6 months postoperatively

  11. Total Testosterone levels [ Time Frame: UP TO 6 MONTHS ]
    Patients were evaluated preoperatively, at 1 month and 6 months postoperatively



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
SEXUAL ACTIVE
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935503


Locations
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Turkey
Fatih Sultan Mehmet Research and Training Hospital
Istanbul, Turkey, 34734
Sponsors and Collaborators
Fatih Sultan Mehmet Training and Research Hospital
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Responsible Party: ANIL ERGIN, Dr Anil ERGIN , General Surgery , Asistant doctor, Fatih Sultan Mehmet Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03935503    
Other Study ID Numbers: ANIL ERGIN1
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ANIL ERGIN, Fatih Sultan Mehmet Training and Research Hospital:
Quality of life
Inguinal Hernia
Lichtenstein repair
Sexual Function
Total Extraperitoneal Repair
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal