Midline Restoration After HYbriD Hernia RepAir Surgery (HYDRA) (HYDRA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Incisional Hernia of Midline of Abdomen
• Intervention / Treatment: Procedure: Hybrid Surgery

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 Type: Observational
• Enrollment (Estimated): 52

Contacts and Locations

• Study Contact: Name: Lucas Visscher, BSC; Phone Number: +310107043683; Email: l.visscher.1@erasmusmc.nl

Study Locations

• Netherlands
  • Leiden, Netherlands
    • Alrijne Hospital
    • Contact: Willem Hueting, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for Hybrid repair of their incisional hernia

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Incisional Hernia patients; Patients with an Incisional Hernia, who present in the participating center	Procedure: Hybrid Surgery; Hybrid incisional hernia repair, as described by Van den Dop et al. (2021); Other Names: three-step incisional hybrid repair (TIHR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Medtronic; Alrijne Hospital
• Investigators: Principal Investigator: Pieter Tanis, Prof. dr., Erasmus Medical Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: December 15, 2023
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Repair; Hybrid; Incisional Hernia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: 8612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No