Intraperitoneal Mesh-Implementation After Laparotomy

Incisional Hernia Clinical Trial

Official title:

Intraperitoneal Mesh-Implementation After Laparotomy to Reduce Risk of Incisional Hernia: a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01003067
• Other study ID #: 364/07
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2008
• Est. completion date: June 2020

Study information

• Verified date: August 2019
• Source: Kantonsspital Liestal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 267
• Est. completion date: June 2020
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent

• Median Laparotomy

Exclusion Criteria:

• Bowel perforation

• Pregnancy

• Palliative surgery

• Drug abuse

• Age under 18

• Mental disability

• Allergy to mesh components

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

Device:
• Mesh implementation
Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Liestal	Liestal	BL

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Liestal

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia.	Secondary endpoints are the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years.	5 Years