Midline Restoration After HYbriD Hernia RepAir Surgery (HYDRA)

NCT06286124 | Not Yet Recruiting

• 1 other identifier: 8612
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Incisional Hernia of Midline of Abdomen

Keywords

Incisional Hernia; Repair; Hybrid

Outcome Measures

Primary Outcomes (1)

• Mean peak torque 1 year

  The functioning of the abdominal wall in Nm/kg as assessed by a BioDex

  12 months

Secondary Outcomes (8)

• Mean peak torque 2 years

  24 months

• Recurrent Incisional Hernia

  1 month, 12 months and 24 months

• Severity of surgical complications

  1 month

• Surgical complications

  1 month

• General Quality of Life

  pre-operative, 12 months and 24 months

Study Arms (1)

Incisional Hernia patients

Patients with an Incisional Hernia, who present in the participating center

Procedure: Hybrid Surgery

Interventions

Hybrid Surgery PROCEDURE

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

Also known as: three-step incisional hybrid repair (TIHR)

Incisional Hernia patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for Hybrid repair of their incisional hernia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Medtronic: collaborator
• Alrijne Hospital: collaborator

Study Sites (1)

Alrijne Hospital

Leiden, Netherlands

Location

Related 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.

  PMID: 32920734 BACKGROUND

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Pieter Tanis, Prof. dr.

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucas Visscher, BSC

CONTACT

+310107043683; l.visscher.1@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: February 29, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)