Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh

Overview

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

Full Title of Study: “Clinical and Sonographic Outcome After Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh in the Retro-rectus (Sublay) Position”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: Single (Participant)
  • Study Primary Completion Date: December 31, 2022

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.

Interventions

  • 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)

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Recurrance rate in sonography
    • Time Frame: 12 months after surgery
    • 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 .
  • Recurrance rate clinically
    • Time Frame: 12 months after surgery
    • 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 .

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Spital Limmattal Schlieren
  • Provider of Information About this Clinical Study
    • Principal Investigator: Prof Urs Zingg, Head of Department of Surgery – Spital Limmattal Schlieren
  • Overall Official(s)
    • Urs Zingg, Study Chair, Spital Limmattal Schlieren
  • Overall Contact(s)
    • Patrizia Heeb, 044 733 11 11, patrizia.heeb@spital-limmattal.ch

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.