Inguinal HerniaNCT04303182
LESS TEP vs. Three Port TEP for Inguinal Hernia Repair
A study testing Standard 3 port TEP and LESS TEP in people with Inguinal Hernia, run by Sofia Med Hospital at 1 site in Bulgaria.
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/. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Standard 3 port TEP and LESS TEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBulgaria
- Study dates
- 2 Jan 2020to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoendoscopic Single-site Versus Three Port Totally Extraperitoneal Hernia Repair: A Prospective Double Blinded Randomized Clinical Trial
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/.
Read the 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.
- Conditions
- Inguinal Hernia
- Being tested
- Standard 3 port TEP, LESS TEP
- Keywords
- TEP, LESS TEP, Inguinal Hernia, Laparoscopic Surgery, Recurrence inguinal hernia, Primary inguinal hernia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard 3 port TEPProcedure or surgery
3 port TEP inguinal hernia repair with 10mm. port under the umbilicus and two 5mm. port in line under the 10mm. port
LESS TEPProcedure or surgery
TEP inguinal hernia repair with one vertical skin incision under the umbilicus
| Study group | Role | What they receive |
|---|---|---|
| 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 ). Receives: Procedure: Standard 3 port TEP |
| LESS TEP | Active comparator | Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm. Receives: Procedure: LESS TEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
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).
Measured: 24hours
Postoperative Pain
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).
Measured: 1 week
Secondary outcomes (6)
Operating Time
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).
Measured: During operation
Intraoperative Complications
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).
Measured: During operation
Length of Hospital Stay
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).
Measured: From end of surgery until hospital discharge (typically within 1-3 days postoperatively).
Postoperative Complications
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).
Measured: Within 4 weeks postoperatively.
Recurrence of Hernia
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.
Measured: During the entire follow-up period (up to 2 years)
Patient Satisfaction
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start2 Jan 2020
- Primary completion1 Jan 2021
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sofia Med Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303182
- Sponsor's protocol ID
- 204
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2020
- Last updated
- 17 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoendoscopic Single-site Versus Three Port Totally Extraperitoneal Hernia Repair: A Prospective Double Blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04303182
- Acronym / sponsor ID
- 204
- Conditions
- Inguinal Hernia
- Keywords
- TEP, LESS TEP, Inguinal Hernia, Laparoscopic Surgery, Recurrence inguinal hernia, Primary inguinal hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sofia Med HospitalUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Posted 17 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard 3 port TEP | Active comparator | Procedure: Standard 3 port TEPGroup A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ). |
| LESS TEP | Active comparator | Procedure: LESS TEPGroup B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard 3 port TEP3 port TEP inguinal hernia repair with 10mm. port under the umbilicus and two 5mm. port in line under the 10mm. port | Procedure or surgery | Standard 3 port TEP |
| LESS TEPTEP inguinal hernia repair with one vertical skin incision under the umbilicus | Procedure or surgery | LESS TEP |
Primary outcome
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).
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).
6 secondary outcomes
Operating Time
Time frame: During operation
Intraoperative Complications
Time frame: During operation
Length of Hospital Stay
Time frame: From end of surgery until hospital discharge (typically within 1-3 days postoperatively).
Postoperative Complications
Time frame: Within 4 weeks postoperatively.
Recurrence of Hernia
Time frame: During the entire follow-up period (up to 2 years)
Patient Satisfaction
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard 3 port TEP and LESS TEP in people with Inguinal Hernia, run by Sofia Med Hospital at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain (time frame: 24hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.