Mesh Fixation in Lichtenstein Hernioplasty

NCT ID: NCT01592942

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a prospective, randomized multi-centre study to find out most safe, feasible, painless and cost-effective mesh fixation method in inguinal hernia operation. Three mesh fixation techniques are compared to find out best technique in local anaesthesia Lichtenstein operation. Our hypothesis is that glue fixation is safe, simple and cheap method compared to conventional Lichtenstein technique.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Some 650 patients with inguinal hernia are operated using Lichtenstein operation in local anaesthesia. Mesh fixation is performed using 3 methods: Optilene™ mesh + cyanoacrylate glue (n=200), self-fixing Parietex Progrip™ mesh (n=200) and non-absorbable sutures with Ultrapro™ mesh (n=200). Operative time and pain scores, immediate postoperative outcome, quality-of-life and total costs are followed 1, 7, 30 days and 1 and 5 years postoperatively.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inguinal Hernia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

inguinal hernia mesh fixation glue Lichtenstein

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

glue fixation

Optilene™ mesh 60 g/m2 (B. Braun), fixation Histoacryl™ cyanoacrylate glue (price 14+37 euros)

Group Type EXPERIMENTAL

Histoacryl

Intervention Type DEVICE

cyanoacrylate glue fixation of mesh 1 ml

self-gripping

ProGrip™ mesh 60 g/m2 (Covidien, USA) (price 113 euros)

Group Type ACTIVE_COMPARATOR

Progrip

Intervention Type DEVICE

self-gripping mesh

suture fixation

Ultrapro™ mesh 28 g/m2 (Ethicon, USA) (price 45 euros) fixated by non-absorbable sutures

Group Type ACTIVE_COMPARATOR

sutures (prolene 3-0)

Intervention Type DEVICE

non-absorbable suture fixation 3-0

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Histoacryl

cyanoacrylate glue fixation of mesh 1 ml

Intervention Type DEVICE

Progrip

self-gripping mesh

Intervention Type DEVICE

sutures (prolene 3-0)

non-absorbable suture fixation 3-0

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Histoacryl glue Parietex Progrip prolene 3-0

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* primary or recurrent inguinal hernia
* unilateral or bilateral

Exclusion Criteria

* femoral hernia
* massive scrotal hernia
* allergy to polypropylene
* patient's refusal
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Paijat-Hame Hospital District

OTHER

Sponsor Role collaborator

North Karelia Central Hospital

OTHER

Sponsor Role collaborator

East Savo Hospital District

OTHER

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hannu Paajanen

PhD, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hannu EK Paajanen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kuopio University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kuopio University Hospital

Kuopio, , Finland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Finland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hannu EK Paajanen, MD, PhD

Role: CONTACT

Phone: +358-40-3589905

Email: [email protected]

Kirsi Rönkä, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hannu EK Paajanen, MD, PhD

Role: primary

Kirsi Rönkä, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KUH 31//2012

Identifier Type: REGISTRY

Identifier Source: secondary_id

KUH5200627

Identifier Type: -

Identifier Source: org_study_id