NCT04303182

Brief 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/.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
2 years until next milestone

Results Posted

Study results publicly available

July 17, 2026

Completed
Last Updated

July 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

February 26, 2020

Results QC Date

February 21, 2026

Last Update Submit

June 18, 2026

Conditions

Inguinal Hernia

Keywords

TEPLESS TEPInguinal HerniaLaparoscopic SurgeryRecurrence inguinal herniaPrimary inguinal hernia

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    1 week

Secondary Outcomes (6)

  • Operating Time

    During operation

  • Intraoperative Complications

    During operation

  • Length of Hospital Stay

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

  • Postoperative Complications

    Within 4 weeks postoperatively.

  • Recurrence of Hernia

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

  • +1 more secondary outcomes

Study Arms (2)

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 ).

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.

Procedure: LESS TEP

Interventions

Standard 3 port TEPPROCEDURE

3 port TEP inguinal hernia repair with 10mm. port under the umbilicus and two 5mm. port in line under the 10mm. port

Standard 3 port TEP
LESS TEPPROCEDURE

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

LESS TEP

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sofiamed Hospital

Sofia, Bulgaria

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was conducted at a single center, which may limit the generalizability of the findings to other institutions and healthcare settings. Although randomization was performed, blinding was limited to the early postoperative period, as blinding beyond 24 hours was not feasible due to the nature of the surgical interventions.

Results Point of Contact

Title
Single-Incision Versus Standard Three-Port Total Extraperitoneal Repair for Inguinal Hernia.
Organization
UMHAT Sofiamed
katya.todorowa@gmail.com
+359884744833

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2020

First Posted

March 10, 2020

Study Start

January 2, 2020

Primary Completion

January 1, 2021

Study Completion

July 31, 2024

Last Updated

July 17, 2026

Results First Posted

July 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

BU(1)