Clinical trial NCT04303182: LESS TEP vs. Three Port TEP for Inguinal Hernia Repair
Official title: Laparoendoscopic Single-site Versus Three Port Totally Extraperitoneal Hernia Repair: A Prospective Double Blinded Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia
Keywords: TEP
LESS TEP
Inguinal Hernia
Laparoscopic Surgery
Recurrence inguinal hernia
Primary inguinal hernia
Lead sponsor: Sofia Med Hospital
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Postoperative Pain
timeFrame: 24hours
measure: Postoperative Pain
timeFrame: 1 week
Secondary outcomes:
measure: Operating time
timeFrame: During operation
measure: Intraoperative complications
timeFrame: During operation
measure: Length of hospital stay
timeFrame: 24 hours
measure: Postoperative complications
timeFrame: 1 week; 4 weeks
measure: Recurrence of hernia
timeFrame: 4 weeks; 3 months; 1 year
measure: Cosmetic scar score
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Sofiamed Hospital
Study officials:
References: