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Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh

Primary Purpose

Abdominal Hernia

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Selective Sonography of the ventral abdominal hernia level
Sponsored by
Spital Limmattal Schlieren
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Hernia focused on measuring Abdominal Hernia, Ventral Hernia, Atraumatic mesh

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Spital Limmattal

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Retrospective

Prospective

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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 .
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 .

Secondary Outcome Measures

Pain and sensation of the mesh measured by the Carolinas Comfort Scale questionnaire
Clinical subjective outcome 1
Limitations in quality of life questionnaire
Clinical subjective outcome 2
Daily activities measured HerQLes questionnaire
Clinical subjective outcome 3

Full Information

First Posted
January 7, 2020
Last Updated
April 12, 2023
Sponsor
Spital Limmattal Schlieren
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1. Study Identification

Unique Protocol Identification Number
NCT04435340
Brief Title
Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh
Official Title
Clinical and Sonographic Outcome After Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh in the Retro-rectus (Sublay) Position
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 22, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spital Limmattal Schlieren

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Hernia
Keywords
Abdominal Hernia, Ventral Hernia, Atraumatic mesh

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
retro- and prospective arm
Masking
Participant
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Retrospective
Arm Type
Other
Arm Description
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.
Arm Title
Prospective
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Selective Sonography of the ventral abdominal hernia level
Intervention Description
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)
Primary Outcome Measure Information:
Title
Recurrance rate in sonography
Description
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 .
Time Frame
12 months after surgery
Title
Recurrance rate clinically
Description
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 .
Time Frame
12 months after surgery
Secondary Outcome Measure Information:
Title
Pain and sensation of the mesh measured by the Carolinas Comfort Scale questionnaire
Description
Clinical subjective outcome 1
Time Frame
12 months after surgery
Title
Limitations in quality of life questionnaire
Description
Clinical subjective outcome 2
Time Frame
12 months after surgery
Title
Daily activities measured HerQLes questionnaire
Description
Clinical subjective outcome 3
Time Frame
12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urs Zingg
Organizational Affiliation
Spital Limmattal Schlieren
Official's Role
Study Chair
Facility Information:
Facility Name
Spital Limmattal
City
Schlieren
State/Province
Zurich
ZIP/Postal Code
8952
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh

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