Incisional Hernia of Midline of Abdomen
Conditions
Keywords
Incisional Hernia, Repair, Hybrid
Brief 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.
Detailed description
Rationale: Abdominal wall functioning has been reported to be higher in patients that underwent open incisional hernia repair compared to laparoscopic incisional hernia repair. With the use of a recently developed hybrid approach, we aim for a functional anatomical restoration of the linea alba while also achieving the technical advantages of the hybrid approach. Objective: The main objective is to asses functional anatomical restoration of the linea alba through functioning in mean peak torque, and ultrasound examination. Study design: Multicentre prospective cohort study. Study population: Adult patients with a midline incisional hernia ≥4 cm and ≤10 cm. Intervention: Not applicable. Main study parameters/endpoints: The primary objective of this study is to assess anatomical restoration and function of the linea alba one year after surgery by ultrasonography and measuring the mean peak torque during trunk flexion using a BioDex(trademark) machine. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No risk is associated with participation other than known complications for incisional hernia repair. HYDRA is part of standard care in the Alrijne Hospital, and the technique has previously been published. The mesh used in this study is being used on a world-wide scale. We do not expect additional risks with this study. As participants have to visit the Erasmus Medical Center (Erasmus MC) an additional three times and have to fill in additional questionnaires, there is a burden for enrolled patients.
Interventions
PROCEDUREHybrid Surgery
Hybrid incisional hernia repair, as described by Van den Dop et al. (2021)
Sponsors
Medtronic
Alrijne Hospital
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean peak torque 1 year | 12 months | The functioning of the abdominal wall in Nm/kg as assessed by a BioDex |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent Incisional Hernia | 1 month, 12 months and 24 months | Ultrasonography examination of the abdominal wall for the detection of a recurrent incisional hernia. |
| Severity of surgical complications | 1 month | Through Clavien-Dindo classification |
| Surgical complications | 1 month | Type of complication will be recorded as a free-text field |
| Mean peak torque 2 years | 24 months | The functioning of the abdominal wall in Nm/kg as assessed by a BioDex |
| Mesh specific Quality of Life | 1 month, 12 months and 24 months | 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. |
| Scar satisfaction | pre-operative, 1 day, 1 month | Visual Analogue Scale for the how satisfied patients are with the new scar from the surgery, reaching from 0 to 10. |
| Pain in the abdominal region | pre-operative, 1 day, 1 month | Visual Analogue Scale for pain in the region of the hernia reaching from 0 to 10. |
| General Quality of Life | pre-operative, 12 months and 24 months | Measure quality of life using the Short Form Health Survey, a 36-question questionnaire |
Countries
Netherlands
Contacts
Primary ContactLucas Visscher, BSC
Outcome results
None listed