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Intraperitoneal Mesh-Implementation After Laparotomy

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ClinicalTrials.gov Identifier: NCT01003067
Recruitment Status : Unknown
Verified August 2019 by Christoph A. Maurer, MD, Kantonsspital Liestal.
Recruitment status was:  Active, not recruiting
First Posted : October 28, 2009
Results First Posted : April 17, 2017
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Christoph A. Maurer, MD, Kantonsspital Liestal

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Incisional Hernia Device: Mesh implementation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intraperitoneal Mesh-Implementation After Laparotomy to Reduce Risk of Incisional Hernia: a Prospective Randomized Controlled Trial
Study Start Date : March 2008
Actual Primary Completion Date : May 2013
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
No Intervention: No Mesh
Experimental: Mesh Implementation Device: Mesh implementation
Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy [ Time Frame: 2 years ]
    Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy.


Secondary Outcome Measures :
  1. Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia. [ Time Frame: 5 Years ]
    Secondary endpoints are the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003067


Locations
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Switzerland
Kantonsspital Liestal
Liestal, BL, Switzerland, 4410
Sponsors and Collaborators
Kantonsspital Liestal
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Christoph A. Maurer, MD, Prof. Dr. med. Christoph A. Maurer, Kantonsspital Liestal
ClinicalTrials.gov Identifier: NCT01003067    
Other Study ID Numbers: 364/07
First Posted: October 28, 2009    Key Record Dates
Results First Posted: April 17, 2017
Last Update Posted: August 15, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes