LESS TEP vs. Three Port TEP for Inguinal Hernia Repair
- Conditions
- Inguinal Hernia
- Interventions
- Procedure: LESS TEPProcedure: Standard 3 port TEP
- Registration Number
- NCT04303182
- Lead Sponsor
- Sofia Med Hospital
- Brief Summary
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/.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Age between 18 and 90 years
- Willing to participate in this study and signed an informed consent.
- Diagnosed inguinal hernia - primary or recurrence
- ASA class I, II and III
- Age under 18 years and above 90 years
- Strangulated hernia
- Patients with severe chronic diseases or cardiopulmonary dysfunction, who can't undergo general anesthesia
- Patients who prefer a certain surgical approach
- Patients who undergo surgery procedures for chronic pain after inguinal hernia repair
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LESS TEP LESS TEP Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm. Standard 3 port TEP Standard 3 port TEP Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).
- Primary Outcome Measures
Name Time Method Postoperative Pain 1 week 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.
- Secondary Outcome Measures
Name Time Method Operating time During operation Intraoperative complications During operation Assessment of interoperation procedure of the incident of spermaduct, vessel and other organ damage
Recurrence of hernia 4 weeks; 3 months; 1 year Postoperative complications 1 week; 4 weeks Urinary infections; Seroma; Hematoma
Length of hospital stay 24 hours Cosmetic scar score 4 weeks Scar evaluation using Patient and Observer Scar Assessment Scale (POSAS) 4 week after the surgery
Trial Locations
- Locations (1)
Sofiamed Hospital
🇧🇬Sofia, Bulgaria