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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
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
unknown

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
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

February 26, 2020

Last Update Submit

June 17, 2023

Conditions

Inguinal Hernia

Keywords

TEPLESS TEPInguinal HerniaLaparoscopic SurgeryRecurrence inguinal herniaPrimary inguinal hernia

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (6)

  • Operating time

    During operation

  • Intraoperative complications

    During operation

  • Length of hospital stay

    24 hours

  • Postoperative complications

    1 week; 4 weeks

  • Recurrence of hernia

    4 weeks; 3 months; 1 year

  • +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

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

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

BU(1)