Trial Outcomes & Findings for LESS TEP vs. Three Port TEP for Inguinal Hernia Repair (NCT NCT04303182)
NCT ID: NCT04303182
Last Updated: 2026-07-17
Results Overview
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).
COMPLETED
NA
200 participants
24hours
2026-07-17
Participant Flow
Participants were prospectively recruited at the Department of Surgery, University Hospital "Sofiamed", Sofia, Bulgaria, between January and October 2020. Adult patients with unilateral or bilateral inguinal hernia scheduled for elective surgery were screened during outpatient visits or hospital admission. Eligibility was assessed after standard preoperative evaluation. Written informed consent was obtained prior to enrollment. A total of 200 patients were randomized 1:1 to LESS-TEP or standard.
Before randomization, all patients underwent standard preoperative assessment, including medical history, physical examination, laboratory testing, and anesthesiology evaluation. Eligibility was confirmed according to predefined inclusion and exclusion criteria. Written informed consent was obtained from all participants prior to allocation. Only eligible and consented patients were randomized to the intervention groups.
Participant milestones
| Measure |
Standard 3 Port TEP
Group A: Participants underwent standard laparoscopic total extraperitoneal (TEP) inguinal hernia repair using a conventional three-port approach. The procedure was performed under general anesthesia following established surgical technique and institutional standards.
|
LESS TEP
Group B: Participants underwent laparoendoscopic single-site total extraperitoneal (LESS-TEP) inguinal hernia repair performed through a single infraumbilical skin incision using standard laparoscopic instruments. The procedure was carried out under general anesthesia according to institutional protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
100
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard 3 Port TEP
n=100 Participants
Group A: The 3-port TEP group consisted of adult patients with unilateral or bilateral inguinal hernia scheduled for elective laparoscopic repair. Most participants were male. The group included patients across a wide age spectrum and various body mass index categories. Preoperative anesthesiology assessment showed ASA physical status classes I to IV, predominantly ASA I-II. The distribution of hernia laterality and hernia types was comparable to the LESS-TEP group. Patients with and without a history of prior abdominal surgery were included.
|
LESS TEP
n=100 Participants
Group B: The LESS-TEP group included adult patients diagnosed with unilateral or bilateral inguinal hernia. The majority of participants were male. Patients covered a broad age range and included individuals with normal body weight, overweight, and obesity. Preoperative anesthesiology risk ranged from ASA physical status class I to IV, with most patients classified as low to moderate risk (ASA I-II). Both unilateral and bilateral hernias were represented, as well as different hernia types. Patients with and without previous abdominal surgery were included.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=200 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
65 Participants
n=100 Participants
|
72 Participants
n=100 Participants
|
137 Participants
n=200 Participants
|
|
Age, Categorical
>=65 years
|
35 Participants
n=100 Participants
|
28 Participants
n=100 Participants
|
63 Participants
n=200 Participants
|
|
Age, Continuous
|
52.1 year
STANDARD_DEVIATION 15.4 • n=100 Participants
|
49.9 year
STANDARD_DEVIATION 15.7 • n=100 Participants
|
51.0 year
STANDARD_DEVIATION 15.6 • n=200 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=100 Participants
|
6 Participants
n=100 Participants
|
15 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=100 Participants
|
94 Participants
n=100 Participants
|
185 Participants
n=200 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
ASA class
|
1.99 units on a scale
STANDARD_DEVIATION 0.70 • n=100 Participants
|
2.00 units on a scale
STANDARD_DEVIATION 0.79 • n=100 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 0.75 • n=200 Participants
|
PRIMARY outcome
Timeframe: 24hoursPostoperative 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).
Outcome measures
| Measure |
Standard 3 Port TEP
n=100 Participants
Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).
|
LESS TEP
n=100 Participants
Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm.
|
|---|---|---|
|
Postoperative Pain
|
4.80 score on a scale
Standard Deviation 1.71
|
4.67 score on a scale
Standard Deviation 1.81
|
PRIMARY outcome
Timeframe: 1 weekPostoperative 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).
Outcome measures
| Measure |
Standard 3 Port TEP
n=100 Participants
Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).
|
LESS TEP
n=100 Participants
Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm.
|
|---|---|---|
|
Postoperative Pain
|
1.09 score on a scale
Standard Deviation 1.0
|
1.08 score on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: During operationOperative 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).
Outcome measures
| Measure |
Standard 3 Port TEP
n=100 Participants
Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).
|
LESS TEP
n=100 Participants
Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm.
|
|---|---|---|
|
Operating Time
|
49.57 minutes
Standard Deviation 19.84
|
48.93 minutes
Standard Deviation 18.90
|
SECONDARY outcome
Timeframe: During operationNumber 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).
Outcome measures
| Measure |
Standard 3 Port TEP
n=100 Participants
Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).
|
LESS TEP
n=100 Participants
Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm.
|
|---|---|---|
|
Intraoperative Complications
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Standard 3 Port TEP
n=100 Participants
Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).
|
LESS TEP
n=100 Participants
Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm.
|
|---|---|---|
|
Length of Hospital Stay
|
1.37 day
Standard Deviation 0.72
|
1.50 day
Standard Deviation 0.93
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Standard 3 Port TEP
n=100 Participants
Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).
|
LESS TEP
n=100 Participants
Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm.
|
|---|---|---|
|
Postoperative Complications
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard 3 Port TEP
n=100 Participants
Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).
|
LESS TEP
n=100 Participants
Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm.
|
|---|---|---|
|
Recurrence of Hernia
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearPatient 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).
Outcome measures
| Measure |
Standard 3 Port TEP
n=100 Participants
Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).
|
LESS TEP
n=100 Participants
Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm.
|
|---|---|---|
|
Patient Satisfaction
|
9.16 score on a scale
Standard Deviation 1.11
|
9.12 score on a scale
Standard Deviation 1.36
|
Adverse Events
Standard 3 Port TEP
LESS TEP
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Single-Incision Versus Standard Three-Port Total Extraperitoneal Repair for Inguinal Hernia.
UMHAT Sofiamed
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place