NCT04211142

Brief Summary

This investigation will be a double-armed, randomized prospective study designed to compare open (Lichtenstein Technique) versus laparoscopic (TAPP) repair of primary unilateral inguinal hernia. Chronic pain, restriction of activities and esthetical outcome will be evaluated preoperatively and postoperatively, at 1, 4 and 12 months, using the European Registry for Abdominal Wall Hernias Quality of Life score (EuraHS-QoL score).

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
216

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
recruiting

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

First Submitted

Initial submission to the registry

December 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 26, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

5.5 years

First QC Date

December 22, 2019

Last Update Submit

February 27, 2024

Conditions

Hernia, Inguinal

Keywords

Hernia, InguinalPainChronic PainQuality of LifeLaparoscopic SurgeryCyanoacrylatesMesh, Surgical

Outcome Measures

Primary Outcomes (1)

  • Chronic pain

    Pain scores (0-10) using the European Registry for Abdominal Wall Hernias Quality of Life Instrument (EuraHS Quality of Life questionnaire). Each question has a scale from 0-10, whereas 0 is considered the best outcome.

    1 year

Secondary Outcomes (5)

  • Restrictions of activities

    1 year

  • Cosmetic discomfort

    1 year

  • Duration of surgery

    Surgery

  • Rate of postoperative complications

    30 days

  • Early recurrences

    1-year

Study Arms (2)

Laparoscopic repair

ACTIVE COMPARATOR

Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair)

Procedure: Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair)

Open repair

ACTIVE COMPARATOR

Open Inguinal Hernia Repair (Lichtenstein repair)

Procedure: Open Inguinal Hernia Repair (Lichtenstein repair)

Interventions

Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair)PROCEDURE

Laparoscopic inguinal hernia repair

Laparoscopic repair
Open Inguinal Hernia Repair (Lichtenstein repair)PROCEDURE

Open Inguinal Hernia Repair

Open repair

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary inguinal hernia
  • unilateral hernia

You may not qualify if:

  • bilateral hernia
  • recurrent hernia
  • incarcerated hernia
  • large scrotal hernia
  • known femoral hernia
  • need for associated procedures
  • not able to understand the questionaire
  • immunosuppression (including corticosteroids, radiotherapy, chemotherapy)
  • chronic renal failure (hemodialysis)
  • active infection
  • pregnancy
  • allergy to polypropylene or cyanoacrylate
  • patient's refusal and/or absence of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínic

Barcelona, 08006, Spain

RECRUITING

Related Publications (2)

  • Hoyuela C, Juvany M, Carvajal F, Veres A, Troyano D, Trias M, Martrat A, Ardid J, Obiols J, Lopez-Cano M. Randomized clinical trial of mesh fixation with glue or sutures for Lichtenstein hernia repair. Br J Surg. 2017 May;104(6):688-694. doi: 10.1002/bjs.10488. Epub 2017 Feb 20.

    PMID: 28218406BACKGROUND

  • Muysoms FE, Vanlander A, Ceulemans R, Kyle-Leinhase I, Michiels M, Jacobs I, Pletinckx P, Berrevoet F. A prospective, multicenter, observational study on quality of life after laparoscopic inguinal hernia repair with ProGrip laparoscopic, self-fixating mesh according to the European Registry for Abdominal Wall Hernias Quality of Life Instrument. Surgery. 2016 Nov;160(5):1344-1357. doi: 10.1016/j.surg.2016.04.026. Epub 2016 Jun 14.

    PMID: 27316825BACKGROUND

MeSH Terms

Conditions

Hernia, InguinalPainChronic Pain

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Salvador Guillaumes, MD, PhD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

  • Nils Jimmy Hidalgo, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

  • Irene Bachero, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Salvador Guillaumes, MD, PhD

CONTACT

+ 34 687 79 54 58guillaumes@clinic.cat

Irene Bachero, MD

CONTACT

+34 627 31 59 56ibachero@clinic.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2019

First Posted

December 26, 2019

Study Start

January 20, 2020

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations

ES(1)