Clinical Trials Directory

Trials / Completed

CompletedNCT03935503

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
Phase
Study type
Observational
Enrollment
42 (actual)
Sponsor
Fatih Sultan Mehmet Training and Research Hospital · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETEPBy 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.
PROCEDURELichtenstein 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.

Timeline

Start date
2017-07-01
Primary completion
2018-01-01
Completion
2019-04-01
First posted
2019-05-02
Last updated
2019-05-02

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT03935503. Inclusion in this directory is not an endorsement.