Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh

NCT04435340 | Completed

• 1 other identifier: 2018-00122
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Abdominal Hernia

Keywords

Abdominal Hernia; Ventral Hernia; Atraumatic mesh

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pain and sensation of the mesh measured by the Carolinas Comfort Scale questionnaire

  12 months after surgery

• Limitations in quality of life questionnaire

  12 months after surgery

• Daily activities measured HerQLes questionnaire

  12 months after surgery

Study Arms (2)

Retrospective

OTHER

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

Prospective

OTHER

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

Interventions

Selective Sonography of the ventral abdominal hernia level DIAGNOSTIC_TEST

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)

Prospective; Retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Inability to comply with the study protocol

Sponsors & Collaborators

• Spital Limmattal Schlieren: lead

Study Sites (1)

Spital Limmattal

Schlieren, Canton of Zurich, 8952, Switzerland

Location

MeSH Terms

Conditions

Hernia, Abdominal; Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Urs Zingg

  Spital Limmattal Schlieren

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Surgery

Model Details: retro- and prospective arm

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: June 17, 2020
• Study Start: March 22, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 13, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)