NCT05750368

Brief Summary

The aim was to evaluate outcomes after epigastric hernia repair in women on a nationwide basis. The primary outcome iss recurrence - secondary outcomes are readmission, operation for complication, risk factors for recurrence, and readmittance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,031

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

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, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

February 20, 2023

Last Update Submit

March 5, 2023

Conditions

Epigastric HerniaWomen With Epigastric Hernias

Outcome Measures

Primary Outcomes (1)

  • operation for recurrence

    operation for recurrence during the observation period

    4 year

Secondary Outcomes (2)

  • Readmittance

    90 days

  • operation for complications

    90 days

Study Arms (1)

women undergoing epigastric hernia repair

all women who have undergone epigastric hernia repair open or laparoscopic in Denmark during af 4-year period from January 1st, 2018, to Dec 31st, 2021.

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsall women undergoing repair
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients undergoing ventral hernia repair in Denmark.

You may qualify if:

  • All female patients undergoing elective repair with a laparoscopic or open technique for an epigastric hernia were included.

You may not qualify if:

  • umbilical or incisional hernias, male patients, recurrent hernia repairs, and hernia repairs performed in relation to other surgical procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

Study Design

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

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 1, 2023

Study Start

September 1, 2022

Primary Completion

January 1, 2023

Study Completion

February 1, 2023

Last Updated

March 7, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)