LESS TEP vs. Three Port TEP for Inguinal Hernia Repair

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04303182
• Other study ID #: 204
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: June 2023
• Source: Sofia Med Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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/.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: July 31, 2024
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• 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
• LESS TEP
TEP inguinal hernia repair with one vertical skin incision under the umbilicus

Locations

Country	Name	City	State
Bulgaria	Sofiamed Hospital	Sofia

Sponsors (1)

Lead Sponsor	Collaborator
Sofia Med Hospital

Country where clinical trial is conducted

Bulgaria, 

Outcome

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