LESS TEP vs. Three Port TEP for Inguinal Hernia Repair

Sofia Med Hospital

Status: Active, not recruiting

Conditions: Inguinal Hernia

Treatments: Procedure: LESS TEP; Procedure: Standard 3 port TEP

Study type: Interventional

Funder types: Other

Identifiers

NCT04303182

204

Details and patient eligibility

About

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/.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Standard 3 port TEP

Active Comparator group

Description:

Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).

Treatment:

Procedure: Standard 3 port TEP

LESS TEP

Active Comparator group

Description:

Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm.

Treatment:

Procedure: LESS TEP