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Intraperitoneal Mesh-Implementation After Laparotomy

Primary Purpose

Incisional Hernia

Status

Unknown status

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Mesh implementation

About this trial

This is an interventional treatment trial for Incisional Hernia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Informed consent
Median Laparotomy

Exclusion Criteria:

Bowel perforation
Pregnancy
Palliative surgery
Drug abuse
Age under 18
Mental disability
Allergy to mesh components

Sites / Locations

Kantonsspital Liestal

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Mesh

Mesh Implementation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01003067

First Posted

October 27, 2009

Last Updated

August 14, 2019

Sponsor

Kantonsspital Liestal

1. Study Identification

Unique Protocol Identification Number

NCT01003067

Brief Title

Intraperitoneal Mesh-Implementation After Laparotomy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 2008 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kantonsspital Liestal

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Incisional Hernia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

267 (Actual)

8. Arms, Groups, and Interventions

Arm Title

No Mesh

Arm Type

No Intervention

Arm Title

Mesh Implementation

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Mesh implementation

Intervention Description

Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.

Primary Outcome Measure Information:

Title

Number of Participants With Incisional Hernia At 2 Years Following Median Laparotomy

Description

Primary endpoint was the incidence of incisional hernias at 2 years following midline laparotomy.

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Feasibility of Mesh-implementation Even After Colorectal Surgery, Find Risk Factors for Wound Infection and Incisional Hernia.

Description

Secondary endpoints are the feasibility, the safety of the mesh stripe implantation including postoperative pain, and the incidence of incisional hernias at 5 years.

Time Frame

5 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Kantonsspital Liestal

City

Liestal

State/Province

ZIP/Postal Code

4410

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

30824961

Citation

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. Erratum In: World J Surg. 2019 Mar 29;:

Results Reference

derived

PubMed Identifier

29159603

Citation

Brosi 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.

Results Reference

derived

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Intraperitoneal Mesh-Implementation After Laparotomy

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