Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh

Clinical and Sonographic Outcome After Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh in the Retro-rectus (Sublay) Position

Patients who underwent ventral abdominal hernia repair with self adhering, atraumatic mesh in sublay position are examined for their recurrence rate

Study Overview

• Status: Completed
• Conditions: Abdominal Hernia
• Intervention / Treatment: Diagnostic test: Selective Sonography of the ventral abdominal hernia level

Detailed Description

The study includes all patients operated from 11.03.2014 to 31.12.2020. Patients will undergo a Sonography at least one year after surgery. The patients operated form 11.03.2014 to date are therefore a retrospective cohort, the patients from to date until 31.12.2020 a prospective cohort. This method is used to achieve the highest possible number of patients in a define period of time with no alteration of surgical technique.

All patients in the retrospective cohort are contacted at least 1 year after surgery and/or 3 years after surg ery via phone call or letter, informed about the study and asked to participate. In case of informed consent, they are invited to the study site. They are asked to complete the questionnaires and they undergo a Sonography of the ventral abdomen.

All patients in the prospective cohort are informed about the study and asked to participate in the outpatient clinic before surgery. In case of informed consent, they are invited to the study site at least one year and three years, respectively, after surgery. They are asked to complete the questionnaires and they undergo an ultrasound of the ventral abdomen.

The latest follow up should be completed by 31.03.2022.

For both, the retro- and prospective arm, the time needed for the follow-up appointment is approximately 1 hour. The completion of the ultrasound is estimated to take 20 minutes, the questionnaires is estimated to take 20-30 minutes.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Zurich
    • Schlieren, Zurich, Switzerland, 8952
      • Spital Limmattal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age older than 18 years
• Initially suffering from ventral abdominal hernia
• Performance of open ventral abdominal hernia repair with self-adhering, atraumatic mesh (Adhesix ®)
• Informed Consent as documented by signature (Appendix: Informed Consent Form)

Exclusion Criteria:

• Inability to comply with the study protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Retrospective; All patients in the retrospective cohort are contacted at least 1 year after surgery and/or 3 years after surgery via phone call or letter, informed about the study and asked to participate. In case of informed consent, they are invited to the study site. They are asked to complete the questionnaires and they undergo a Sonography of the ventral abdomen.	Diagnostic test: Selective Sonography of the ventral abdominal hernia level; The primary outcome of the study is measured by an radiologist experienced in abdominal ultrasound with a linear ultrasound transducer (ML 6-15 Hz). In case of aggravated examination circumstances a different ultrasound transducer is used (linear 9 L or convex C 1-6 Hz)
Other: Prospective; All patients in the prospective cohort are informed about the study and asked to participate in the outpatient clinic before surgery. In case of informed consent, they are invited to the study site at least one year and three years, respectively, after surgery. They are asked to complete the questionnaires and they undergo an ultrasound of the ventral abdomen.	Diagnostic test: Selective Sonography of the ventral abdominal hernia level; The primary outcome of the study is measured by an radiologist experienced in abdominal ultrasound with a linear ultrasound transducer (ML 6-15 Hz). In case of aggravated examination circumstances a different ultrasound transducer is used (linear 9 L or convex C 1-6 Hz)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrance rate in sonography	The primary outcome is the recurrence rate of ventral abdominal hernia determined by clinical examination and sonography. A recurrence is defined if intraabdominal structures (i.e. intestines, omentum, preperitoneal fat tissue) reach ventrally of the facial layers .	12 months after surgery
Recurrance rate clinically	The primary outcome is the recurrence rate of ventral abdominal hernia determined by clinical examination. A recurrence is defined if intraabdominal structures (i.e. intestines, omentum, preperitoneal fat tissue) reach ventrally of the facial layers .	12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain and sensation of the mesh measured by the Carolinas Comfort Scale questionnaire	Clinical subjective outcome 1	12 months after surgery
Limitations in quality of life questionnaire	Clinical subjective outcome 2	12 months after surgery
Daily activities measured HerQLes questionnaire	Clinical subjective outcome 3	12 months after surgery

Collaborators and Investigators

• Sponsor: Spital Limmattal Schlieren
• Investigators: Study Chair: Urs Zingg, Spital Limmattal Schlieren

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2018
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: January 7, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (Actual): June 17, 2020

Study Record Updates

• Last Update Posted (Actual): April 13, 2023
• Last Update Submitted That Met QC Criteria: April 12, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Ventral Hernia; Abdominal Hernia; Atraumatic mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Hernia, Ventral; Hernia, Abdominal; Internal Hernia
• Other Study ID Numbers: 2018-00122

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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