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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
| Alrijne Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incisional Hernia patients | Patients with an Incisional Hernia, who present in the participating center |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid Surgery | Procedure | Hybrid incisional hernia repair, as described by Van den Dop et al. (2021) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean peak torque 1 year | The functioning of the abdominal wall in Nm/kg as assessed by a BioDex | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean peak torque 2 years | The functioning of the abdominal wall in Nm/kg as assessed by a BioDex | 24 months |
| Recurrent Incisional Hernia | Ultrasonography examination of the abdominal wall for the detection of a recurrent incisional hernia. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients scheduled for Hybrid repair of their incisional hernia
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucas Visscher, BSC | Contact | +310107043683 | l.visscher.1@erasmusmc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Pieter Tanis, Prof. dr. | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alrijne Hospital | Leiden | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32920734 | Background | 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. |
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The data is partly retrieved from patient files and from questionnaires (after informed consent). Even though the data is pseudonymized, there is too much risk of confidentiality breach.
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| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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| 1 month, 12 months and 24 months |
| Severity of surgical complications | Through Clavien-Dindo classification | 1 month |
| Surgical complications | Type of complication will be recorded as a free-text field | 1 month |
| 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 |
| 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 |
| 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 |
| 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 |
| D010335 | Pathologic Processes |