Prophylactic Mesh Implantation for the Prevention of Incisional Hernia (ProphMesh)

Mesh Implantation for Prophylaxis of Incisional Hernia

Incisional hernias are primarily repaired using prosthetic meshes. In Switzerland such meshes are mainly implanted via open or laparoscopic approach. The differential impact of these two types of surgical technique on recurrence rate will be investigated with this study.

With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia repair will be investigated prospectively. Hernia recurrence is the main outcome measure.

Study Overview

• Status: Completed
• Conditions: Incisional Hernias
• Intervention / Treatment: Procedure: Abdominal surgery

Detailed Description

Background

Incisional hernia is one of the most common complication in general abdominal surgery. An overall incidence of 20% has been found in retrospective studies, ranging in up to 50% of patients with selected risk factors such as obesity.

In the general surgical patient the current standard is the closure of the abdominal wall using a running, slowly absorbable suture. With this well established clinical practice the incidence remains high and incisional hernia repair must be performed frequently in order to treat patients'symptoms and to prevent progression of the hernia an possible complications.

Consequently, in high risk patients prophylactic mesh implantation is performed routinely in our institution.

Objective

• Occurrence of at least two of the following factors:

  • Male gender
  • Malignant tumor present
  • Body mass index above 25kg/m2
  • Previous laparotomy
• Elective operation
• Patient >18 years
• Written informed consent

Methods

Prospective,two armed, controlled, randomized study

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Switzerland
  • Berne, Switzerland, 3010
    • Dep. of Visceral and transplant surgery, Berne University Hospital

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Population with a high risk for incisional hernia formation

Description

Inclusion Criteria:

• Occurrence of at least two of the following factors:

  • Male gender
  • Malignant tumor present
  • Body mass index above 25
  • Previous laparatomy
• Elective operation
• Patient > 18 years
• Written informed consent

Exclusion Criteria

• Previous intra-abdominal mesh placement
• Emergency procedures
• Previous incisional hernia
• Inflammatory bowel disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control Group; The main operation will be performed as planned. For the closure of the abdominal wall, a standard technique will be applied using a running suture of PDS 1 loop. The distance of the sutures to the fascial border is 1cm and the distance between two stitches is not more than 1cm. The total length of suture is at least 4 times the total length of the abdominal incision	Procedure: Abdominal surgery; Intraoperative mesh implantation
Treatment Group; The main operation will be performed as planned. Prior to the closure of the abdominal wall a mesh will be implanted in a standardized fashion: A Dynamesh IPOM mesh will be used for the present study. The mesh has a width of 15cm and is tailored to overlap lateral and cranial boarders at least 5cm. The mesh will be placed intra-abdominally and fixed using intra-abdominal stitches using Prolene 2/0 in all four corners. After the initial fixation of the mesh in all quadrants, the boarders of the mesh will be adapted using Prolene 2/0 running sutures. The fixation aims to prevent any intestinal structures to herniate onto the mesh. Afterwards, the abdominal wall is closed as described in the control group.	Procedure: Abdominal surgery; Intraoperative mesh implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of incisional hernia	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Postoperative complications	3 years
Direct in-hospital costs	3 years
Intraoperative complications	3 years

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Principal Investigator: Guido Beldi, Prof. Dr. med., Berne, University Hospital, Univesrity of Berne, Switzerland

Publications and helpful links

General Publications

• Kohler A, Lavanchy JL, Lenoir U, Kurmann A, Candinas D, Beldi G. Effectiveness of Prophylactic Intraperitoneal Mesh Implantation for Prevention of Incisional Hernia in Patients Undergoing Open Abdominal Surgery: A Randomized Clinical Trial. JAMA Surg. 2019 Feb 1;154(2):109-115. doi: 10.1001/jamasurg.2018.4221.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: September 14, 2010
• First Submitted That Met QC Criteria: September 14, 2010
• First Posted (Estimate): September 16, 2010

Study Record Updates

• Last Update Posted (Actual): April 11, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Prophylaxis; Incisional hernias; Preperitoneal mesh
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: KEK 094/10