NCT01325246

Brief Summary

The risk for recurrence after ventral hernia repair is often based on reoperation rates with short follow-up rather than recurrences identified by clinical examinations. The purpose of current study is find the real incidence of recurrences 3 years after ventral hernia repair and to compare with the reoperation rate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
945

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Shorter than P25 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

Study Start

First participant enrolled

September 1, 2010

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 29, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 15, 2024

Status Verified

August 1, 2024

Enrollment Period

6 months

First QC Date

September 14, 2010

Last Update Submit

August 14, 2024

Conditions

Ventral Hernia

Keywords

ventral herniarepairclinicalreoperation

Outcome Measures

Primary Outcomes (1)

  • Clinical recurrence after ventral hernia repair

    up to 4 years

Secondary Outcomes (1)

  • explanations for not having a recurrence repair

    up to 4 years

Eligibility Criteria

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

1200 patients who had a ventral hernia repair in 2007

You may qualify if:

  • Primary ventral hernia repair performed in the region of Zealand in Denmark

You may not qualify if:

  • Patients who died and patients not resident in region Zealand

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of surgery, Køge Hospital

Køge, 4600, Denmark

Location

Related Publications (1)

  • Helgstrand F, Rosenberg J, Kehlet H, Strandfelt P, Bisgaard T. Reoperation versus clinical recurrence rate after ventral hernia repair. Ann Surg. 2012 Dec;256(6):955-8. doi: 10.1097/SLA.0b013e318254f5b9.

    PMID: 22580941DERIVED

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Frederik Helgstrand, MD

    dept. of surgery, Køge Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 14, 2010

First Posted

March 29, 2011

Study Start

September 1, 2010

Primary Completion

March 1, 2011

Study Completion

June 1, 2011

Last Updated

August 15, 2024

Record last verified: 2024-08

Locations

DK(1)