- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03935503
COMPARISON OF LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR AND LICHTENSTEIN HERNIA REPAIR (HERNIA)
COMPARISON OF LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR AND LICHTENSTEIN HERNIA REPAIR FOR SEXUAL, SENSORY, LIFE QUALITY AND URINARY FUNCTIONS
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey, 34734
- Fatih Sultan Mehmet Research and Training Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
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.
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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.
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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UP TO 6 MONTHS
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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 :
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UP TO 6 MONTHS
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SF-36 Quality of Life Scale
Time Frame: UP TO 6 MONTHS
|
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
|
UP TO 6 MONTHS
|
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.
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UP TO 6 MONTHS
|
Beck Depression Scale
Time Frame: UP TO 6 MONTHS
|
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
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UP TO 6 MONTHS
|
Inguinal Region Discrimination Test ( DT)
Time Frame: UP TO 6 MONTHS
|
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
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UP TO 6 MONTHS
|
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.
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UP TO 6 MONTHS
|
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
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UP TO 6 MONTHS
|
Follicle Stimulating Hormone levels
Time Frame: UP TO 6 MONTHS
|
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
|
UP TO 6 MONTHS
|
Luteinising Hormone levels
Time Frame: UP TO 6 MONTHS
|
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
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UP TO 6 MONTHS
|
Total Testosterone levels
Time Frame: UP TO 6 MONTHS
|
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
|
UP TO 6 MONTHS
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANIL ERGIN1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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