Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh
NCT ID: NCT04435340
Last Updated: 2023-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2018-03-22
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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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.
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)
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.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Spital Limmattal Schlieren
OTHER
Responsible Party
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Prof Urs Zingg
Head of Department of Surgery
Principal Investigators
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Urs Zingg
Role: STUDY_CHAIR
Spital Limmattal Schlieren
Locations
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Spital Limmattal
Schlieren, Canton of Zurich, Switzerland
Countries
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Other Identifiers
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2018-00122
Identifier Type: -
Identifier Source: org_study_id
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