Intraperitoneal Mesh-Implementation After Laparotomy
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|ClinicalTrials.gov Identifier: NCT01003067|
Recruitment Status : Active, not recruiting
First Posted : October 28, 2009
Results First Posted : April 17, 2017
Last Update Posted : August 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Incisional Hernia||Device: Mesh implementation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||267 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|No Intervention: No Mesh|
|Experimental: Mesh Implementation||
Device: Mesh implementation
Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
- 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.
- 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.
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
|Liestal, BL, Switzerland, 4410|