LESS TEP vs. Three Port TEP for Inguinal Hernia Repair

NCT ID: NCT04303182

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-02
• Study Completion Date: 2024-07-31

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.

Conditions

Inguinal Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard 3 port TEP

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

Group Type: ACTIVE_COMPARATOR

Standard 3 port TEP

Intervention Type: PROCEDURE

3 port TEP inguinal hernia repair with 10mm. port under the umbilicus and two 5mm. port in line under the 10mm. port

LESS TEP

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

Group Type: ACTIVE_COMPARATOR

LESS TEP

Intervention Type: PROCEDURE

TEP inguinal hernia repair with one vertical skin incision under the umbilicus

Interventions

Standard 3 port TEP

3 port TEP inguinal hernia repair with 10mm. port under the umbilicus and two 5mm. port in line under the 10mm. port

Intervention Type: PROCEDURE

LESS TEP

TEP inguinal hernia repair with one vertical skin incision under the umbilicus

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sofia Med Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sofiamed Hospital

Sofia, , Bulgaria

Countries

Bulgaria

Other Identifiers

204

Identifier Type: -

Identifier Source: org_study_id