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OpenTrials
Completed

NCT Number: NCT05750368

Long-term Outcomes After Epigastric Hernia Repair in Women - a Nationwide Database Study

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.

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Key information

Conditions

Epigastric Hernia Women With Epigastric Hernias

Age range

18 year–120 year

Sex eligibility

Female

Study type

Observational

Primary location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

About this study

Aim Outcomes after epigastric hernia repair are rarely reported independently. Furthermore, women have the highest prevalence of epigastric hernia repair in the age of 41-50 years.

The aim of this study was to evaluate long-term outcomes after epigastric hernia repairs in women on a nationwide basis.

Methods Nationwide database cohort study using prospectively recorded data from the Danish Hernia Database from women undergoing elective repair for epigastric hernias, during a 4-year period (2018-2021). A 100% follow-up was obtained by combining intra-operative data with data from the National Civil Register (NRC). The primary outcome was operation for recurrence, secondary outcomes were readmission and operation for complications. We compared open vs. laparoscopic repairs, and subgroup analysis were made for open repairs (sutured vs. mesh).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. operation for recurrence

    Time frame: 4 year

    operation for recurrence during the observation period

Secondary outcomes

  1. Readmittance

    Time frame: 90 days

    readmittance within 90 days after repair

  2. operation for complications

    Time frame: 90 days

    90 days operation for complications

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Herlev Hospital

Registry information

Acronym: EPI-WOMEN

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 1, 2023
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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