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COMPARISON OF LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR AND LICHTENSTEIN HERNIA REPAIR

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03935503
Acronym
HERNIA
Enrollment
42
Registered
2019-05-02
Start date
2017-07-01
Completion date
2019-04-01
Last updated
2019-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

Quality of life, Inguinal Hernia, Lichtenstein repair, Sexual Function, Total Extraperitoneal Repair

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.

Interventions

PROCEDURETEP

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.

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.

Sponsors

Fatih Sultan Mehmet Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
International Sexual Function Index (IFIF)UP TO 6 MONTHSPatients 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 ScoreUP TO 6 MONTHSPatients 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 ScaleUP TO 6 MONTHSPatients were evaluated preoperatively, at 1 month and 6 months postoperatively
Visual Analog Pain ScaleUP TO 6 MONTHSPatients 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 ScaleUP TO 6 MONTHSPatients were evaluated preoperatively, at 1 month and 6 months postoperatively
Inguinal Region Discrimination Test ( DT)UP TO 6 MONTHSPatients were evaluated preoperatively, at 1 month and 6 months postoperatively
DN4 Neuropathic Pain SurveyUP TO 6 MONTHSPatients 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 urinationUP TO 6 MONTHSIn 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 levelsUP TO 6 MONTHSPatients were evaluated preoperatively, at 1 month and 6 months postoperatively
Luteinising Hormone levelsUP TO 6 MONTHSPatients were evaluated preoperatively, at 1 month and 6 months postoperatively
Total Testosterone levelsUP TO 6 MONTHSPatients were evaluated preoperatively, at 1 month and 6 months postoperatively

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026