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.
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.
Study Type
OBSERVATIONAL
Enrollment
52
Hybrid incisional hernia repair, as described by Van den Dop et al. (2021)
Alrijne Hospital
Leiden, Netherlands
Mean peak torque 1 year
The functioning of the abdominal wall in Nm/kg as assessed by a BioDex
Time frame: 12 months
Mean peak torque 2 years
The functioning of the abdominal wall in Nm/kg as assessed by a BioDex
Time frame: 24 months
Recurrent Incisional Hernia
Ultrasonography examination of the abdominal wall for the detection of a recurrent incisional hernia.
Time frame: 1 month, 12 months and 24 months
Severity of surgical complications
Through Clavien-Dindo classification
Time frame: 1 month
Surgical complications
Type of complication will be recorded as a free-text field
Time frame: 1 month
General Quality of Life
Measure quality of life using the Short Form Health Survey, a 36-question questionnaire
Time frame: pre-operative, 12 months and 24 months
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.
Time frame: 1 month, 12 months and 24 months
Scar satisfaction
Visual Analogue Scale for the how satisfied patients are with the new scar from the surgery, reaching from 0 to 10.
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Time frame: pre-operative, 1 day, 1 month
Pain in the abdominal region
Visual Analogue Scale for pain in the region of the hernia reaching from 0 to 10.
Time frame: pre-operative, 1 day, 1 month