NCT01280370

Brief Summary

Nowadays incisional hernia 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. Hypothesis: Laparoscopic incisional hernia repair is associated with a lower recurrence rate compared to open incisional hernia repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
371

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2011

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

7.8 years

First QC Date

January 19, 2011

Last Update Submit

February 13, 2019

Conditions

Incisional Hernia Repair

Keywords

Incisional hernia repair

Outcome Measures

Primary Outcomes (1)

  • recurrence rate

    36 months

Secondary Outcomes (6)

  • surgical site infections

    36 months

  • chronic pain

    36 months

  • length of hospital stay

    3 months

  • morbidity

    3 months

  • cosmetic results

    36 months

  • +1 more secondary outcomes

Study Arms (2)

1

1.patients treated in a laparoscopic manner

2.

2\. patients treated in open operative manner

Procedure: Abdominal surgery

Interventions

Abdominal surgeryPROCEDURE

intraoperative mesh implantation

2.

Eligibility Criteria

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

Patients undergoing incisional hernia repair

You may qualify if:

  • Patients over 18 years old
  • Written informed consent
  • Primary or recurrent incisional hernia

You may not qualify if:

  • Systemic or severe local infections
  • Emergency procedures

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

Study Officials

  • Guido Beldi, Prof. Dr. med.

    Berne, University Hospital, University of Berne, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 19, 2011

First Posted

January 20, 2011

Study Start

September 1, 2010

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

CH(1)