Incisional Hernia of Midline of Abdomen Clinical Trial
— HYDRAOfficial title:
Midline Restoration After HYbriD Incisional Hernia RepAir (HYDRA) With the SymbotexTM Mesh
NCT number | NCT06286124 |
Other study ID # | 8612 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 2024 |
Est. completion date | April 2028 |
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.
Status | Not yet recruiting |
Enrollment | 52 |
Est. completion date | April 2028 |
Est. primary completion date | April 2027 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Alrijne Hospital | Leiden |
Lead Sponsor | Collaborator |
---|---|
Erasmus Medical Center | Alrijne Hospital, Medtronic |
Netherlands,
van den Dop LM, de Smet GHJ, Bus MPA, Lange JF, Koch SMP, Hueting WE. A new three-step hybrid approach is a safe procedure for incisional hernia: early experiences with a single centre retrospective cohort. Hernia. 2021 Dec;25(6):1693-1701. doi: 10.1007/s10029-020-02300-9. Epub 2020 Sep 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean peak torque 1 year | The functioning of the abdominal wall in Nm/kg as assessed by a BioDex | 12 months | |
Secondary | Mean peak torque 2 years | The functioning of the abdominal wall in Nm/kg as assessed by a BioDex | 24 months | |
Secondary | Recurrent Incisional Hernia | Ultrasonography examination of the abdominal wall for the detection of a recurrent incisional hernia. | 1 month, 12 months and 24 months | |
Secondary | Severity of surgical complications | Through Clavien-Dindo classification | 1 month | |
Secondary | Surgical complications | Type of complication will be recorded as a free-text field | 1 month | |
Secondary | General Quality of Life | Measure quality of life using the Short Form Health Survey, a 36-question questionnaire | pre-operative, 12 months and 24 months | |
Secondary | Mesh specific Quality of Life | The Carolina Comfort Scale, which is a mesh-specific quality of life questionnaire, will be used in order to assess satisfaction with the placed mesh. | 1 month, 12 months and 24 months | |
Secondary | Scar satisfaction | Visual Analogue Scale for the how satisfied patients are with the new scar from the surgery, reaching from 0 to 10. | pre-operative, 1 day, 1 month | |
Secondary | Pain in the abdominal region | Visual Analogue Scale for pain in the region of the hernia reaching from 0 to 10. | pre-operative, 1 day, 1 month |
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