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Completed

NCT Number: NCT01848184

A Prospective Study in Patients Undergoing Primary Ventral Hernia Repair Using Parietex™ Composite Ventral Patch

The objective of this study is to assess the recurrence rate following the use of PARIETEX™ Composite Ventral Patch in primary ventral hernia repair by open approach with intra-peritoneal positioning.

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Key information

Conditions

Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Surgery - Imelda Hospital, Bonheiden, Belgium

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About this study

Prospective, multicenter, multinational non-comparative study.

Primary Endpoint: Primary hernia recurrence* rate at 24 month follow-up. The evaluation of hernia recurrence will be performed during a physical examination and by ultrasonography.

Secondary Endpoints: Primary hernia recurrence* rate at 1, 6 and 12 month follow-up. The evaluation of hernia recurrence will be performed during a physical examination and confirmed by ultrasonography.

(*Recurrence is defined as a clinically manifested bulge or a protrusion exacerbated by a Valsalva maneuver.)

Safety Parameters:

Deep and superficial infection (A Surgical Site Infection (SSI) will be defined in the study according to the Centers for Disease Control and Prevention (CDC) criteria for diagnosis of SSI).

Pain / Chronic pain Other post-operative complications (complications related to visceral adhesions, Ileus, seroma, hematoma...) Analgesics consumption Risk factors (severity and treatment) Efficacy Parameters: Recurrence of primary ventral hernia Operative time Time of the mesh positioning Length of Hospital Stay Ease of use (Mesh handling and manipulability, comfort of use …) Return to daily activities/ work Patient satisfaction Patient comfort (Carolina's™ Comfort scale (CCS) - QoL questionnaire)

Visit Schedule:

Baseline visit (Preoperative) & Operative/Discharge visit

Post-Op:

Phone call Day 10

1 month 6 months 12 months 24 months

Duration: 12 months recruitment and 24 months follow-up Up to 12 sites in Europe and the United States will be included in this study

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients (adult ≥ 18 years) at participating centres undergoing primary ventral hernia repair with the device by open approach
  • Signed informed consent form by the patient or the legally authorized representative
  • Intraoperative inclusion criteria :Size of the defect: ≤ 4 cm

Exclusion criteria

  • Emergency procedure
  • Current participation in other trials
  • History of previous hernia at the same location.
  • Pregnant women: Women who are known or suspected to be pregnant, or who are planning to become pregnant during the study follow-up period
  • Patient < 18 years
  • BMI > 35
  • ASA score ≥ 4
  • The investigator determined that the patient will not be able to comply with the required follow-up visits

Treatment and study plan

PARIETEX™ Composite Ventral Patch

Device

PARIETEX™ Composite Ventral Patch for ventral hernia repair

Primary outcomes

  1. Primary Hernia Recurrence Rate at 24 Month Follow-up.

    Time frame: 24 month follow-up

    The number of participants with hernia recurrence at 24 months, assessed during a physical examination and by ultrasonography.

Secondary outcomes

  1. Recurrence Rate at 1, 6 and 12 Month Follow-up

    Time frame: 1, 6 and 12 month follow-up.

    The number of participants with hernia recurrence at 1 month, 6 month and 12 month follow-up visit.

Other outcomes

  1. Pain Score at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months

    Time frame: Various (Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months)

    Pain evaluation as determined by a 10-point pain intensity numerical rating scale (NRS) ranging from 0 (no pain) to 10 (worst pain). Scores reported at Baseline, Discharge, Day10, 1 Month, 6 Months, 12 Months & 24 Months

  2. Summary of Risk Factors at Baseline

    Time frame: Baseline

    Summary of Risk factors at Baseline. Risk factors include: Smoker, Obesity, Diabetes T1 & T2, Cancer, Cardiovascular disease, Hypertension, COPD, Chronic desease requiring analgesic or corticoid consumption

  3. Mesh Handling Ease of Use During Surgery

    Time frame: Per- operative

    Ease of use (mesh handling and comfort of use). Surgeons were asked if they were satisfied or completely satisfied, unsatisfied or completely dissatisfied

  4. Other Relevant Data: Operative Time

    Time frame: Per- operative

    Operative time during surgery for all patient receiving PCO ventral patch

  5. Other Relevant Data: Time of Mesh Positioning

    Time frame: Per- operative

    The time of the mesh positioning during surgery

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

A Multicentre Prospective Study in Patients Undergoing Ventral Hernia Repair by Open Approach With Intraperitoneal Positioning Using Parietex™ Composite Ventral Patch - Panacea Study.

Acronym: Panacea

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
May 7, 2013
Registry last updated
Jul 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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