Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh

Abdominal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04435340
• Other study ID #: 2018-00122
• Status: Completed
• Phase: N/A
• Start date: March 22, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Spital Limmattal Schlieren
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Hernia
• Hernia
• Hernia, Abdominal
• Hernia, Ventral
• Internal Hernia

Intervention

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)

Locations

Country	Name	City	State
Switzerland	Spital Limmattal	Schlieren	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Spital Limmattal Schlieren

Country where clinical trial is conducted

Switzerland, 

Outcome

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