Incisional Hernia of Midline of AbdomenHYDRANCT06286124
Midline Restoration After HYbriD Hernia RepAir Surgery (HYDRA)
An observational study of Incisional Hernia of Midline of Abdomen, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia of Midline of Abdomen
- What is being tested?
- Hybrid Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2024to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients scheduled for Hybrid repair of their incisional hernia
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Midline Restoration After HYbriD Incisional Hernia RepAir (HYDRA) With the SymbotexTM Mesh
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.
Read the 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.
- Conditions
- Incisional Hernia of Midline of Abdomen
- Being tested
- Hybrid Surgery
- Keywords
- Incisional Hernia, Repair, Hybrid
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid SurgeryProcedure or surgery
Also called three-step incisional hybrid repair (TIHR)
Hybrid incisional hernia repair, as described by Van den Dop et al. (2021)
| Study group | Role | What they receive |
|---|---|---|
| Incisional Hernia patients | Patients with an Incisional Hernia, who present in the participating center Receives: Procedure: Hybrid Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean peak torque 1 year
The functioning of the abdominal wall in Nm/kg as assessed by a BioDex
Measured: 12 months
Secondary outcomes (8)
Mean peak torque 2 years
The functioning of the abdominal wall in Nm/kg as assessed by a BioDex
Measured: 24 months
Recurrent Incisional Hernia
Ultrasonography examination of the abdominal wall for the detection of a recurrent incisional hernia.
Measured: 1 month, 12 months and 24 months
Severity of surgical complications
Through Clavien-Dindo classification
Measured: 1 month
Surgical complications
Type of complication will be recorded as a free-text field
Measured: 1 month
General Quality of Life
Measure quality of life using the Short Form Health Survey, a 36-question questionnaire
Measured: 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.
Measured: 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.
Measured: 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.
Measured: pre-operative, 1 day, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study startApr 2024 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incisional Hernia of Midline of AbdomenStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Alrijne Hospital
- Responsible party
- Principal investigator, Prof. dr. Pieter J Tanis, Erasmus Medical Center
- Investigators
- Pieter Tanis, Prof. dr., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286124
- Sponsor's protocol ID
- 8612
- Acronym
- HYDRA
- Status last verified
- Feb 2024
- First submitted
- 15 Dec 2023
- Last updated
- 29 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 32920734
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midline Restoration After HYbriD Incisional Hernia RepAir (HYDRA) With the SymbotexTM Mesh
- ClinicalTrials.gov ID
- NCT06286124
- Acronym / sponsor ID
- HYDRA / 8612
- Conditions
- Incisional Hernia of Midline of Abdomen
- Keywords
- Incisional Hernia, Repair, Hybrid
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic, Alrijne Hospital
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Incisional Hernia patients | – | Procedure: Hybrid SurgeryPatients with an Incisional Hernia, who present in the participating center |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for Hybrid repair of their incisional hernia
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hybrid SurgeryAlso: three-step incisional hybrid repair (TIHR)Hybrid incisional hernia repair, as described by Van den Dop et al. (2021) | Procedure or surgery | Incisional Hernia patients |
Primary outcome
Mean peak torque 1 year
Time frame: 12 months
The functioning of the abdominal wall in Nm/kg as assessed by a BioDex
8 secondary outcomes
Mean peak torque 2 years
Time frame: 24 months
Recurrent Incisional Hernia
Time frame: 1 month, 12 months and 24 months
Severity of surgical complications
Time frame: 1 month
Surgical complications
Time frame: 1 month
General Quality of Life
Time frame: pre-operative, 12 months and 24 months
Mesh specific Quality of Life
Time frame: 1 month, 12 months and 24 months
Scar satisfaction
Time frame: pre-operative, 1 day, 1 month
Pain in the abdominal region
Time frame: pre-operative, 1 day, 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2024.
- Background: PubMed 32920734van 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pieter Tanis, Prof. dr. principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia of Midline of Abdomen, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucas Visscher, BSC (+310107043683, l.visscher.1@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean peak torque 1 year (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06286124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2024.