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Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT02233569
Date of registration:	29/08/2014
Prospective Registration:	No
Primary sponsor:	Polish Hernia Study Group
Public title:	Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair
Scientific title:	COMPARISON OF TWO DIFFERENT CONCEPTS OF MESH AND FIXATION TECHNIQUE IN THE LAPAROSCOPIC OPERATIONS FOR VENTRAL AND INCISIONAL HERNIA - A RANDOMIZED CONTROLLED MONOCENTER TRIAL.
Date of first enrolment:	November 2012
Target sample size:	50
Recruitment status:	Terminated
URL:	http://clinicaltrials.gov/show/NCT02233569
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Phase:	N/A

Countries of recruitment
Poland

Contacts

Name:	Maciej Pawlak, MD
Address:
Telephone:
Email:
Affiliation:

Name:	Maciej Smietanski, PhD
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hernia,Ventral

Hernia, Abdominal

Intervention(s)

Device: Ventralight ST implant

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

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

Device: ETHICON PHYSIOMESH®

Primary Outcome(s)

Pain [Time Frame: 7 days after the surgery]

Pain [Time Frame: 3 months after the surgery]

Secondary Outcome(s)

Pain intensity [Time Frame: 7 days after the surgery]

Number of Participants with Recurrences [Time Frame: up to one year]

Pain intensity [Time Frame: 3 months after the surgery]

Number of Participants with complications. [Time Frame: up to one year]

Pain intensity [Time Frame: 30 days after the surgery]

Pain intensity [Time Frame: 6 months after the surgery]

Secondary ID(s)

PHvsVS

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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