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Completed

NCT Number: NCT04303182

LESS TEP vs. Three Port TEP for Inguinal Hernia Repair

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/.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sofiamed Hospital

Sofia, Bulgaria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

LESS TEP

Procedure

TEP inguinal hernia repair with one vertical skin incision under the umbilicus

Primary outcomes

  1. Postoperative Pain

    Time frame: 24hours

    Postoperative pain will be assessed using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse pain intensity (worse outcome).

  2. Postoperative Pain

    Time frame: 1 week

    Postoperative pain will be assessed using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent worse pain intensity (worse outcome).

Secondary outcomes

  1. Operating Time

    Time frame: During operation

    Operative time will be measured as the duration of the surgical procedure using time in minutes. The measurement starts from skin incision and ends at completion of skin closure. The scale ranges from 0 to no predefined maximum value, with higher values indicating longer operative duration (worse outcome in terms of efficiency).

  2. Intraoperative Complications

    Time frame: During operation

    Number of participants with intraoperative complications, defined as any unintended injury occurring during surgery, including spermatic cord injury (vas deferens), vascular injury, or injury to adjacent organs (e.g., bladder, bowel). The outcome is reported as a count (number of participants), with a range from 0 to total number of participants. Higher values indicate worse outcome (greater complication rate).

  3. Length of Hospital Stay

    Time frame: From end of surgery until hospital discharge (typically within 1-3 days postoperatively).

    Length of hospital stay will be measured as the time in days from completion of surgery to hospital discharge. The outcome is reported as a continuous variable (days), with values ranging from 0 to no predefined maximum. Higher values indicate longer hospitalization (worse outcome in terms of recovery efficiency).

  4. Postoperative Complications

    Time frame: Within 4 weeks postoperatively.

    Number of participants with postoperative complications, defined as the occurrence of urinary tract infection, seroma, or hematoma within the postoperative period. The outcome is reported as a cumulative count of participants experiencing at least one complication within 4 weeks after surgery. The range is from 0 to total number of participants, with higher values indicating worse outcome (higher complication rate).

  5. Recurrence of Hernia

    Time frame: During the entire follow-up period (up to 2 years)

    Number of participants with hernia recurrence, defined as a clinically or radiologically confirmed reappearance of an inguinal hernia at the site of previous repair Hernia recurrence was assessed throughout the follow-up period. The reported value represents the cumulative number of recurrences observed during follow-up of up to 2 years.

  6. Patient Satisfaction

    Time frame: 1 year

    Patient satisfaction with the cosmetic result will be assessed using a numeric rating scale (NRS) ranging from 1 to 10, where 1 indicates not satisfied at all and 10 indicates very satisfied. Higher scores represent better outcome (greater patient satisfaction).

Sponsors and collaborators

Lead sponsor

Sofia Med Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2024
First posted
Mar 10, 2020
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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