Not Yet RecruitingNot Applicable

Midline Restoration After HYbriD Hernia RepAir Surgery (HYDRA)

Netherlands52 participantsStarted 2024-04

Plain-language summary

The goal of this observational study is to learn about the functioning of the abdominal wall in patients who underwent hybrid (open- and laparoscopic) incisional hernia repair. The main objective is to assess the anatomical restoration and function of the linea alba one year after surgery by ultrasonography and mean peak torque during trunk flexion using a BioDex machine.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years or older * Scheduled for elective HYDRA-surgery * Midline incisional hernia larger than 4 centimetres in mean width * Sufficient knowledge of the Dutch language to be able to understand and fill in the questionnaires * Signed informed consent form by patient Exclusion Criteria: * Pregnant at inclusion * Inclusion in other trials with interference of the primary and secondary endpoints * American Society of Anesthesiologists Classification (ASA Classification) \> 3 * Hernia defect larger than 10 centimetres in mean width * Incarcerated hernias or emergency procedure * Unable to perform a trunk flexion * Incapacitated patients

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean peak torque 1 year

Timeframe: 12 months

Trial details

NCT IDNCT06286124

SponsorErasmus Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-04

Contact for this trial

Lucas Visscher, BSC

+310107043683 l.visscher.1@erasmusmc.nl

View on ClinicalTrials.gov More Incisional Hernia of Midline of Abdomen trials