Inguinal HerniaHERNIANCT03935503
COMPARISON OF LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR AND LICHTENSTEIN HERNIA REPAIR
An observational study of Inguinal Hernia, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- TEP and Lichtenstein repair
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2017to 1 Apr 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: SEXUAL ACTIVE
Who may be able to join
- 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)
Who cannot join
- Patients with previous abdominal and inguinal hernia surgery
- ASA 3-4
- Sexually inactive
- Emergency patients (Etrangule inguinal hernia)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Research and Training Hospital
Istanbul, 34734
About this study
Official title: COMPARISON OF LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR AND LICHTENSTEIN HERNIA REPAIR FOR SEXUAL, SENSORY, LIFE QUALITY AND URINARY FUNCTIONS
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.
Read the 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.
- Conditions
- Inguinal Hernia
- Being tested
- TEP, Lichtenstein repair
- Keywords
- Quality of life, Inguinal Hernia, Lichtenstein repair, Sexual Function, Total Extraperitoneal Repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEPProcedure or surgery
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 repairProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: TEP | |
| 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. Receives: Procedure: Lichtenstein repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Sexual Function Index (IFIF)
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.
Measured: UP TO 6 MONTHS
International Prostatic Symptom Score
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 :
- what is your frequency of feeling that your bladder does not empty after urination
- what is the frequency of needing to urinate in less than 2 hours after urination?
- what is your frequency of stopping several times when you urinate and restart?
- how often do you have difficulty urinating?
- how often did you feel the reduction in the power of your urine?
- how often have you experienced difficulty urinating?
- how many times have you gone to urinate until you get up in the morning?
Measured: UP TO 6 MONTHS
SF-36 Quality of Life Scale
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
Measured: UP TO 6 MONTHS
Visual Analog Pain Scale
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.
Measured: UP TO 6 MONTHS
Beck Depression Scale
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
Measured: UP TO 6 MONTHS
Inguinal Region Discrimination Test ( DT)
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
Measured: UP TO 6 MONTHS
DN4 Neuropathic Pain Survey
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.
Measured: UP TO 6 MONTHS
Uroflowmetry test for urination
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
Measured: UP TO 6 MONTHS
Follicle Stimulating Hormone levels
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
Measured: UP TO 6 MONTHS
Luteinising Hormone levels
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
Measured: UP TO 6 MONTHS
Total Testosterone levels
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
Measured: UP TO 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Jul 2017
- Primary completion1 Jan 2018
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANIL ERGIN, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935503
- Sponsor's protocol ID
- ANIL ERGIN1
- Acronym
- HERNIA
- Status last verified
- May 2019
- First submitted
- 21 Apr 2019
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR AND LICHTENSTEIN HERNIA REPAIR FOR SEXUAL, SENSORY, LIFE QUALITY AND URINARY FUNCTIONS
- ClinicalTrials.gov ID
- NCT03935503
- Acronym / sponsor ID
- HERNIA / ANIL ERGIN1
- Conditions
- Inguinal Hernia
- Keywords
- Quality of life, Inguinal Hernia, Lichtenstein repair, Sexual Function, Total Extraperitoneal Repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Extraperitoneal Repair | – | Procedure: TEPLaparoscopic 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 | – | Procedure: Lichtenstein repairLichtenstein 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SEXUAL ACTIVE
Key inclusion criteria (6 listed)
- Unilateral inguinal hernia (diagnosed by physical examination or imaging)
- Sexual Active
- Male gender
- aged between 18 and 65
- ASA 1-2
Key exclusion criteria (4 listed)
- Patients with previous abdominal and inguinal hernia surgery
- ASA 3-4
- Sexually inactive
- Emergency patients (Etrangule inguinal hernia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEPBy 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. | Procedure or surgery | Total Extraperitoneal Repair |
| Lichtenstein repairAfter 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. | Procedure or surgery | Lichtenstein repair |
Primary outcome
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.
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?
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.
Beck Depression Scale
Time frame: UP TO 6 MONTHS
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
Inguinal Region Discrimination Test ( DT)
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.
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
Follicle Stimulating Hormone levels
Time frame: UP TO 6 MONTHS
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
Luteinising Hormone levels
Time frame: UP TO 6 MONTHS
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
Total Testosterone levels
Time frame: UP TO 6 MONTHS
Patients were evaluated preoperatively, at 1 month and 6 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Sexual Function Index (IFIF) (time frame: UP TO 6 MONTHS). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.