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The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair (CLOSURE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01719718
First received: October 30, 2012
Last updated: December 4, 2014
Last verified: December 2014
  Purpose
A multicenter prospective randomized controlled trial comparing closure versus non-closure of the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomesh™) in laparoscopic ventral hernia repair.

Condition Intervention
Ventral Hernia
Procedure: Closure of hernia defect.
Procedure: No closure of the hernia defect.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Influence of Closing the Gap on Postoperative Seroma and Recurrences in Laparoscopic Ventral Hernia Repair.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Seroma formation after 4 weeks. [ Time Frame: 4 weeks after surgery. ] [ Designated as safety issue: No ]
    The seroma formation is checked by clinical evaluation.


Secondary Outcome Measures:
  • Pain, discomfort and esthetic evaluation after 4 weeks. [ Time Frame: 4 weeks after surgery. ] [ Designated as safety issue: No ]
    Pain, discomfort and esthetic evaluation is performed after 4 weeks by clinical evaluation and the Visual Analogue Scale.

  • Pain, discomfort and esthetic evaluation after 1 year. [ Time Frame: 1 year after surgery. ] [ Designated as safety issue: No ]
    Pain, discomfort and esthetic evaluation is performed after 1 year by clinical evaluation and the Visual Analogue Scale.

  • Pain, discomfort and esthetic evaluation after 2 years. [ Time Frame: 2 years after surgery. ] [ Designated as safety issue: No ]
    Pain, discomfort and esthetic evaluation is performed after 2 years by clinical evaluation and the Visual Analogue Scale.


Estimated Enrollment: 132
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Closure Procedure: Closure of hernia defect.
Laparoscopic ventral hernia repair with closure of the hernia defect (mesh augmentation technique).
Sham Comparator: Non-Closure Procedure: No closure of the hernia defect.
Conventional laparoscopic ventral hernia repair without closure of the hernia defect (defect bridging technique).

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent from the patient or his/her legal representative
  • Ventral or incisional hernia requiring elective surgical repair
  • Diameter between 2 and 5cm in width
  • Midline and flank hernias are eligible

Exclusion Criteria:

  • No written informed consent
  • 'Hostile' abdomen, open abdomen treatment
  • Contraindication to pneumoperitoneum
  • Emergency surgery (incarcerated hernia)
  • Parastomal hernia
  • Subxiphoidal hernia
  • Subcostal hernia
  • Suprapubic hernia
  • Clean-contaminated or contaminated field
  • Hernia diameter >5cm in width
  • Pregnancy
  • Non-compliance
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719718

Locations
Belgium
Algemeen Stedelijk Ziekenhuis
Aalst, Belgium
Imelda Hospital
Bonheiden, Belgium
St Vincentius Hospital
Deinze, Belgium
Ghent University Hospital
Ghent, Belgium, 9000
Maria Middelares
Ghent, Belgium, 9000
Hôpital Mont Godinne
Mont-Godinne, Belgium
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Frederik Berrevoet, MD, PhD, FACS University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01719718     History of Changes
Other Study ID Numbers: 2012/075 
Study First Received: October 30, 2012
Last Updated: December 4, 2014
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
ventral hernia

Additional relevant MeSH terms:
Hernia
Recurrence
Hernia, Ventral
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes
Hernia, Abdominal

ClinicalTrials.gov processed this record on December 02, 2016