NCT02398565

Brief Summary

We will examine the outcome of ventral hernia repair with subsequent pregnancy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7,612

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

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

March 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

March 19, 2015

Last Update Submit

January 11, 2016

Conditions

Hernia, VentralPregnancy

Outcome Measures

Primary Outcomes (1)

  • Recurrence of ventral hernia

    7 years

Study Arms (1)

Cohort

Patients with a history of ventral hernia repair (umbilical/epigastric and incisional) with subsequent pregnancy Ventral hernia repair - perioperative factors of interest: \- mesh vs sutured repair, age, planned vs emergency repair, open vs laparoscopic approach, Pregnancy and delivery - factors of interest: \- vaginal vs caesearan section, single vs multiple pregnancy Subgroup of patients with mesh repair: \- subanalysis on main attributes Subgroup of patients with sutured repair: \- mono- vs multifilament, slowly vs rapidly absorbable

Other: No intervention

Interventions

No interventionOTHER
Cohort

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Nationwide study population of patients registered with a ventral hernia repair in The Danish Hernia Database between January 1 2007 and December 31 2014

You may qualify if:

  • History of ventral hernia repair with subsequent pregnancy
  • Born between January 1 1955 and January 1 1995

You may not qualify if:

  • Registered in the Danish Hernia Database with a non-valid ID-number, i.e. non-Danish resident.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Digestive Disease Center, Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Lars N Jorgensen

    Bispebjerg Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 19, 2015

First Posted

March 25, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2015

Study Completion

October 1, 2015

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

DK(1)