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OpenTrials
Completed

NCT Number: NCT00572962

Prospective Clinical Observational Cohort Study to Evaluate the Use of a Tissue Separating Mesh (Proceed®) in Laparoscopic Ventral Hernia Repair

1. General: antibiotic prophylaxis: cefazoline (Cefacidal™) 2 gram iv administered 30 minutes before surgery 2. Laparoscopic surgery

* at least 5 cm overlap (mesh diameter should exceed hernia size by at least 10 cm) * with or without anchoring transparietal sutures or double crown technique

Completed

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • written informed consent from the patient or his/her legal representative
  • ventral hernia requiring elective surgical repair

Exclusion criteria

  • no written informed consent
  • 'hostile' abdomen; open abdomen treatment
  • contraindication to pneumoperitoneum
  • emergency surgery (incarcerated hernia)
  • parastomal hernia

Treatment and study plan

use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair

Procedure

use of a tissue separating mesh (Proceed®) in Laparoscopic Ventral hernia repair

Primary outcomes

  1. recurrence rate

    Time frame: after 1 year

Secondary outcomes

  1. morbidity rate

    Time frame: perioperative

  2. quality of life

    Time frame: after 1 year

  3. postoperative pain

    Time frame: within 1 week

  4. long term complication rate

    Time frame: after 1 year

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Johnson & Johnson

Registry information

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2007
Registry last updated
Dec 20, 2022

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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