LESS TEP vs. Three Port TEP for Inguinal Hernia Repair

• ClinicalTrials.gov Identifier: NCT04303182
• Recruitment Status: Active, not recruiting
• First Posted: March 10, 2020
• Last Update Posted: June 22, 2023
• Sponsor: Sofia Med Hospital
• Information provided by (Responsible Party): Sofia Med Hospital

Study Description

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/.

Condition or disease	Intervention/treatment	Phase
Inguinal Hernia	Procedure: Standard 3 port TEP; Procedure: LESS TEP	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Double blinded
• Primary Purpose: Treatment
• Official Title: Laparoendoscopic Single-site Versus Three Port Totally Extraperitoneal Hernia Repair: A Prospective Double Blinded Randomized Clinical Trial
• Actual Study Start Date: January 2, 2020
• Actual Primary Completion Date: January 1, 2021
• Estimated Study Completion Date: July 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Postoperative Pain [ Time Frame: 24hours ]
   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.
2. Postoperative Pain [ Time Frame: 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 :

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

Eligibility Criteria

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

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

Contacts and Locations

Locations

Bulgaria

Sofiamed Hospital

Sofia, Bulgaria

Sponsors and Collaborators

Sofia Med Hospital

More Information

• Responsible Party: Sofia Med Hospital
• ClinicalTrials.gov Identifier: NCT04303182
• Other Study ID Numbers: 204
• First Posted: March 10, 2020
• Last Update Posted: June 22, 2023
• Last Verified: June 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sofia Med Hospital:

TEP; LESS TEP; Inguinal Hernia; Laparoscopic Surgery; Recurrence inguinal hernia; Primary inguinal hernia

Additional relevant MeSH terms:

Hernia; Hernia, Inguinal; Pathological Conditions, Anatomical; Hernia, Abdominal