Laparoscopic vs Open Bilateral Inguinal Hernia Repair

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04679116

Enrollment

100

Registered

2020-12-22

Start date

2021-01-02

Completion date

2022-12-31

Last updated

2021-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia Bilateral

Keywords

bilateral inguinal hernia repair

Brief summary

The European Hernia Society Guidelines of 2018 suggest that laparoscopic surgery should be preferred over open surgery for bilateral inguinal hernia repair even though scientific evidence are scarce. We will conduct a prospective, non randomise control trial, to investigate the superiority of one technique over the other.

Interventions

PROCEDURELaparoscopic bilateral inguinal hernia repair

Laparoscopic bilateral inguinal hernia repair

PROCEDUREOpen bilateral inguinal hernia repair

Open bilateral inguinal hernia repair

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

prospective, non randomised

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* bilateral inguinal hernia

Exclusion criteria

* American Society of Anaesthesiology score \>3 * complicated inguinal hernias

Design outcomes

Primary

Measure	Time frame	Description
Post operative Pain	24 hours post surgery	Evaluation of the post operative pain 24 hours after surgery. For the assessment of the pain will be used the Visual Analog Scale (VAS) score. (VAS Score Scale from 0-10, 0 no pain, 10 max pain)

Secondary

Measure	Time frame	Description
urinary retention	8 hours	inability to voluntarily void urine up to 8 hours post surgery
complications	30 days	presence of surgery related complications
days of hospitalization	30 days	days that need to be hospitalised after surgery
chronic pain	1 year	For the evaluation of the chronic pain will be used the registry for abdominal wall hernias Quality of Life questionnaire (EuraHS QoL) scale from 0 to 10. (0 = no pain 10=worst pain imaginable)
foreign body sensation to the inguinal area	1 year	For the evaluation of the foreign body sensation to the inguinal area will be used the Carolinas Comfort Scale (scale from 0 to 5, 0= no symptoms, 5 = disabling symptoms)
recurrence	1 year	recurrence of one or two of the hernias treated at the clinical evaluation one year after surgery

Countries

Greece

Contacts

Primary ContactGeorgios D Koukoulis, MD, PhD

georgios.koukoulis@gmail.com00302413504366

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026