LESS TEP vs. Three Port TEP for Inguinal Hernia Repair

Laparoendoscopic Single-site Versus Three Port Totally Extraperitoneal Hernia Repair: A Prospective Double Blinded Randomized Clinical Trial

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/.

Study Overview

• Status: Active, not recruiting
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Standard 3 port TEP; Procedure: LESS 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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • Sofiamed Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard 3 port TEP; Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).	Procedure: 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
Active Comparator: LESS TEP; Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm.	Procedure: LESS TEP; TEP inguinal hernia repair with one vertical skin incision under the umbilicus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operating time		During operation
Intraoperative complications	Assessment of interoperation procedure of the incident of spermaduct, vessel and other organ damage	During operation
Length of hospital stay		24 hours
Postoperative complications	Urinary infections; Seroma; Hematoma	1 week; 4 weeks
Recurrence of hernia		4 weeks; 3 months; 1 year
Cosmetic scar score	Scar evaluation using Patient and Observer Scar Assessment Scale (POSAS) 4 week after the surgery	4 weeks

Collaborators and Investigators

• Sponsor: Sofia Med Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Actual): January 1, 2021
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: February 26, 2020
• First Submitted That Met QC Criteria: March 8, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 17, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: TEP; Laparoscopic Surgery; Inguinal Hernia; LESS TEP; Recurrence inguinal hernia; Primary inguinal hernia
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: 204 (Fakultät für Psychologie Ethikkommission, Ruhr University of Bochum)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No