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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/.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard 3 port TEP | Active Comparator | Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ). |
|
| LESS TEP | Active Comparator | Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard 3 port TEP | Procedure | 3 port TEP inguinal hernia repair with 10mm. port under the umbilicus and two 5mm. port in line under the 10mm. port |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sofiamed Hospital | Sofia | Bulgaria |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 21, 2026 | |
| Reset | Mar 12, 2026 | |
| Release | Apr 22, 2026 | |
| Reset | May 13, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 21, 2026 | Mar 12, 2026 | |||
| Apr 22, 2026 |
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Double blinded
| LESS TEP | Procedure | TEP inguinal hernia repair with one vertical skin incision under the umbilicus |
|
| 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 |
| May 13, 2026 |
| Jun 18, 2026 |