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Intraperitoneal Mesh-Implementation After Laparotomy

This study is currently recruiting participants.
Verified October 2009 by Kantonsspital Liestal
Sponsor:
Information provided by:
Kantonsspital Liestal
ClinicalTrials.gov Identifier:
NCT01003067
First received: October 27, 2009
Last updated: July 5, 2010
Last verified: October 2009
History of Changes
  Purpose

Aim of the study is to evaluate the risk reduction of intraperitoneal mesh-implementation after laparotomy (Group 1) in a randomized control trial compared with patients with standard abdominal closure (Everett-suture). This is the primary endpoint. Second endpoints are the feasibility of mesh-implementation even after colorectal surgery, find risk factors for wound infection and incisional hernia.


Condition Intervention
Incisional Hernia
 Device: Mesh implementation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intraperitoneal Mesh-Implementation After Laparotomy to Reduce Risk of Incisional Hernia: a Prospective Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by Kantonsspital Liestal:

Primary Outcome Measures:
  • Risk reduction of incisional hernia after laparotomy [ Time Frame: 8 Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Feasibility of mesh-implementation even after colorectal surgery, find risk factors for wound infection and incisional hernia. [ Time Frame: 8 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 230
Study Start Date: March 2008
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Mesh
Experimental: Mesh Implementation Device: Mesh implementation
Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • Median Laparotomy

Exclusion Criteria:

  • Bowel perforation
  • Pregnancy
  • Palliative surgery
  • Drug abuse
  • Age under 18
  • Mental disability
  • Allergy to mesh components
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003067

Contacts
Contact: Daniela A Mueller, MSc, EMBA +41619252154 daniela.mueller@ksli.ch

Locations
Switzerland
Kantonsspital Liestal Recruiting
Liestal, BL, Switzerland, 4410
Sponsors and Collaborators
Kantonsspital Liestal
  More Information

No publications provided

Responsible Party: Maurer Christoph A./ MD, KS Liestal
ClinicalTrials.gov Identifier: NCT01003067     History of Changes
Other Study ID Numbers: 364/07
Study First Received: October 27, 2009
Last Updated: July 5, 2010
Health Authority: Switzerland: Ethical Committee

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 18, 2013