Intraperitoneal Mesh-Implementation After Laparotomy
1 other identifier
interventional
267
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 27, 2009
CompletedFirst Posted
Study publicly available on registry
October 28, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedResults Posted
Study results publicly available
April 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedAugust 15, 2019
August 1, 2019
5.2 years
October 27, 2009
March 6, 2017
August 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy
Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy.
2 years
Secondary Outcomes (1)
Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia.
5 Years
Study Arms (2)
No Mesh
NO INTERVENTIONMesh Implementation
EXPERIMENTALInterventions
Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
Eligibility Criteria
You may qualify if:
- Informed consent
- Median Laparotomy
You may not qualify if:
- Bowel perforation
- Pregnancy
- Palliative surgery
- Drug abuse
- Age under 18
- Mental disability
- Allergy to mesh components
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kantonsspital Liestal
Liestal, Basel-Landschaft, 4410, Switzerland
Related Publications (2)
Glauser PM, Brosi P, Speich B, Kaser SA, Heigl A, Rosenberg R, Maurer CA. Prophylactic Intraperitoneal Onlay Mesh Following Midline Laparotomy-Long-Term Results of a Randomized Controlled Trial. World J Surg. 2019 Jul;43(7):1669-1675. doi: 10.1007/s00268-019-04964-6.
PMID: 30824961DERIVEDBrosi P, Glauser PM, Speich B, Kaser SA, Maurer CA. Prophylactic Intraperitoneal Onlay Mesh Reinforcement Reduces the Risk of Incisional Hernia, Two-Year Results of a Randomized Clinical Trial. World J Surg. 2018 Jun;42(6):1687-1694. doi: 10.1007/s00268-017-4363-2.
PMID: 29159603DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Prof. Christoph A. Maurer
- Organization
- Hirslanden Bern
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med. Christoph A. Maurer
Study Record Dates
First Submitted
October 27, 2009
First Posted
October 28, 2009
Study Start
March 1, 2008
Primary Completion
May 1, 2013
Study Completion
June 1, 2020
Last Updated
August 15, 2019
Results First Posted
April 17, 2017
Record last verified: 2019-08