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

Tracking Information

• First Submitted Date: February 26, 2020
• First Posted Date: March 10, 2020
• Last Update Posted Date: June 22, 2023
• Actual Study Start Date: January 2, 2020
• Actual Primary Completion Date: January 1, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 8, 2020)

• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 8, 2020)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Masking Description:

Double blinded

Primary Purpose: Treatment

• Condition: Inguinal Hernia

Intervention

• 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
• Procedure: LESS TEP
  TEP inguinal hernia repair with one vertical skin incision under the umbilicus

Study Arms

• 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 ).
  Intervention: Procedure: Standard 3 port TEP
• Active Comparator: LESS TEP
  Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm.
  Intervention: Procedure: LESS TEP

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 8, 2020): 200
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 31, 2024
• Actual Primary Completion Date: January 1, 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria

Administrative Information

• NCT Number: NCT04303182
• Other Study ID Numbers: 204
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Sofia Med Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Sofia Med Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Sofia Med Hospital
• Verification Date: June 2023