Midline Restoration After HYbriD Hernia RepAir Surgery (HYDRA)

Incisional Hernia of Midline of Abdomen Clinical Trial

— HYDRA  

Official title:

Midline Restoration After HYbriD Incisional Hernia RepAir (HYDRA) With the SymbotexTM Mesh

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06286124
• Other study ID #: 8612
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: April 2028

Study information

• Verified date: February 2024
• Source: Erasmus Medical Center
• Contact: Lucas Visscher, BSC
• Phone: +310107043683
• Email: l.visscher.1[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical 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 peak torque during trunk flexion using a BioDex machine.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: April 2028
• Est. primary completion date: April 2027
• 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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia
• Incisional Hernia of Midline of Abdomen

Intervention

Procedure:
• Hybrid Surgery
Hybrid incisional hernia repair, as described by Van den Dop et al. (2021)

Locations

Country	Name	City	State
Netherlands	Alrijne Hospital	Leiden

Sponsors (3)

Lead Sponsor	Collaborator
Erasmus Medical Center	Alrijne Hospital, Medtronic

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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

Outcome

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