Intraperitoneal Mesh-Implementation After Laparotomy

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

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.

Study Overview

• Status: Unknown
• Conditions: Incisional Hernia
• Intervention / Treatment: Device: Mesh implementation

• Study Type: Interventional
• Enrollment (Actual): 267
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • BL
    • Liestal, BL, Switzerland, 4410
      • Kantonsspital Liestal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Informed consent
• Median Laparotomy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: No Mesh
EXPERIMENTAL: Mesh Implementation	Device: Mesh implementation; Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kantonsspital Liestal

Publications and helpful links

General Publications

• 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;:
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (ACTUAL): May 1, 2013
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: October 27, 2009
• First Submitted That Met QC Criteria: October 27, 2009
• First Posted (ESTIMATE): October 28, 2009

Study Record Updates

• Last Update Posted (ACTUAL): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: 364/07