Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair

COMPARISON OF TWO DIFFERENT CONCEPTS OF MESH AND FIXATION TECHNIQUE IN THE LAPAROSCOPIC OPERATIONS FOR VENTRAL AND INCISIONAL HERNIA - A RANDOMIZED CONTROLLED MONOCENTER TRIAL.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02233569

Enrollment

Registered

2014-09-08

Start date

2012-11-30

Completion date

2014-02-28

Last updated

2014-09-08

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

Conditions

Hernia, Abdominal, Hernia,Ventral

Keywords

Laparoscopic hernia repair, Ventral hernia, Incisional hernia, IPOM

Brief summary

This is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has been designed as a superiority study to proof the concept of previously published mathematical model of front abdominal wall.

Interventions

PROCEDUREIntraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.

Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Physiomesh (mesh implant) and Securestrap (fixation device)

PROCEDUREIntraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.

Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Ventralight ST (mesh implant) and SofbaFix (fixation device)

DEVICEVentralight ST implant

DEVICEETHICON PHYSIOMESH®

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Informed Consent Form (ICF) signed by the patient or his/her legal representative * primary or secondary ventral hernia less than 20 cm in length and less than 11 cm in width requiring elective surgical repair * recurrence after former abdominal hernia repair WITH MESH * recurrence after suture abdominal hernia repair CAN be included

Exclusion criteria

* no written informed consent * patient under 18 years old * emergency surgery (incarcerated hernia) * patients with expected life time shorter than one year for example due to generalised malignancy * BMI exceeding 40.0kg/m² * contaminated surgical fields * patients on immunosuppression, steroid therapy, constant pain therapy

Design outcomes

Primary

Measure	Time frame	Description
Pain	7 days after the surgery	Presence of pain 7 days after the surgery.

Secondary

Measure	Time frame	Description
Number of Participants with Recurrences	up to one year	The recurrence rate in one year followup.
Number of Participants with complications.	up to one year	The description and percentage distribution of short and long term complications following surgery.
Pain intensity	7 days after the surgery	Intensity of pain measured on a visual analogue scale 7 days after the surgery

Other

Measure	Time frame	Description
Time of the operation	intraoperative	The duration of the surgical procedure

Countries

Poland

Outcome results

None listed

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