NCT01203553

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

6.2 years

First QC Date

September 14, 2010

Last Update Submit

April 10, 2017

Conditions

Incisional Hernias

Keywords

Incisional herniasProphylaxisPreperitoneal mesh

Outcome Measures

Primary Outcomes (1)

  • Incidence of incisional hernia

    3 years

Secondary Outcomes (3)

  • Direct in-hospital costs

    3 years

  • Intraoperative complications

    3 years

  • Postoperative complications

    3 years

Study Arms (2)

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

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

Interventions

Abdominal surgeryPROCEDURE

Intraoperative mesh implantation

Control GroupTreatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Population with a high risk for incisional hernia formation

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Visceral and transplant surgery, Berne University Hospital

Bern, 3010, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 30476940DERIVED

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Guido Beldi, Prof. Dr. med.

    Berne, University Hospital, Univesrity of Berne, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2010

First Posted

September 16, 2010

Study Start

January 1, 2011

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

CH(1)