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 range18 Years

SexALL

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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

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