This study aim to compare efficacy and safety of Laparoendoscopic single site total extraperitoneal inguinal hernia repair /LESS TEP/ and traditional total extraperitoneal hernia repair with 3 ports /TEP/.
This is a prospective, double blinded, randomized trial. It compared of Laparoendoscopic single site total extraperitoneal inguinal hernia repair /LESS TEP/ and traditional total extraperitoneal hernia repair with 3 ports /TEP/. Inguinal hernia is one of the most common surgical diseases. Laparoscopic hernia repairs include two types, TEP and TAPP. Laparoscopic inguinal hernia repair was associated with less post operative pain, a shorter recovery period and better cosmetic results. Efforts are continuing to further reduce the port related morbidities and improve the cosmetic outcomes of laparoscopic surgery, including reduction of the size and number of ports. This has led to the evolution of a novel surgical approach now collectively known as laparoendoscopic single-site surgery. 200 patients will undergo TEP inguinal hernia repair. They will be randomized in two groups by sealed envelope method. Group A: Standard TEP with 3 ports (10mm. and 2 ports of 5mm.). In case of difficulty in Standard 3 port TEP inguinal hernia repair, the procedure will be converted to TAPP. Group B: LESS TEP with single skin incision 2-3cm. In case of difficulty in LESS TEP inguinal hernia repair, the procedure will be converted to standard 3 port repair or TAPP. Patient will be informed at consenting that 3 wound plasters will be applied to their abdomen regardless of whether they are in the single port or 3- ports group so that they would not know which group they have been randomized to. The blind will only be lifted after pain score and area of pain has been recorded before discharge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
3 port TEP inguinal hernia repair with 10mm. port under the umbilicus and two 5mm. port in line under the 10mm. port
TEP inguinal hernia repair with one vertical skin incision under the umbilicus
Sofiamed Hospital
Sofia, Bulgaria
Postoperative Pain
Assessment of post-operative pain according to the visual analog scale pain score - From 0 to 10 - 0 is no pain and 10 is severe pain.
Time frame: 24hours
Postoperative Pain
Assessment of post-operative pain according to the visual analog scale pain score - From 0 to 10 - 0 is no pain and 10 is severe pain.
Time frame: 1 week
Operating time
Time frame: During operation
Intraoperative complications
Assessment of interoperation procedure of the incident of spermaduct, vessel and other organ damage
Time frame: During operation
Length of hospital stay
Time frame: 24 hours
Postoperative complications
Urinary infections; Seroma; Hematoma
Time frame: 1 week; 4 weeks
Recurrence of hernia
Time frame: 4 weeks; 3 months; 1 year
Cosmetic scar score
Scar evaluation using Patient and Observer Scar Assessment Scale (POSAS) 4 week after the surgery
Time frame: 4 weeks
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