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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01719718
First received: October 30, 2012
Last updated: October 31, 2012
Last verified: October 2012
  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 2013 (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
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

Contacts
Contact: Frederik Berrevoet, MD, PhD Frederik.Berrevoet@ugent.be

Locations
Belgium
Algemeen Stedelijk Ziekenhuis Recruiting
Aalst, Belgium
Contact: Van Den Bossche, MD         
Principal Investigator: Van Den Bossche, MD         
Imelda Hospital Recruiting
Bonheiden, Belgium
Contact: Tollens, MD         
Principal Investigator: Tollens, MD         
St Vincentius Hospital Recruiting
Deinze, Belgium
Contact: Berwouts, MD         
Principal Investigator: Berwouts, MD         
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Frederik Berrevoet, MD, PhD       Frederik.Berrevoet@ugent.be   
Principal Investigator: Frederik Berrevoet, MD, PhD, FACS         
Sub-Investigator: Aude Vanlander, MD         
Maria Middelares Recruiting
Ghent, Belgium, 9000
Contact: Muysoms, MD         
Principal Investigator: Muysoms, MD         
Hôpital Mont Godinne Recruiting
Mont-Godinne, Belgium
Contact: Betrand, MD         
Principal Investigator: Bertrand, MD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Frederik Berrevoet, MD, PhD, FACS Ghent University Hospital
  More Information

Additional Information:
No publications provided

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: October 31, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
ventral hernia

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

ClinicalTrials.gov processed this record on August 20, 2014