Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh

Spital Limmattal Schlieren

Status: Completed

Conditions: Abdominal Hernia

Treatments: Diagnostic Test: Selective Sonography of the ventral abdominal hernia level

Study type: Interventional

Funder types: Other

Identifiers

NCT04435340

2018-00122

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Retrospective

Other group

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.

Treatment:

Diagnostic Test: Selective Sonography of the ventral abdominal hernia level

Prospective

Other group

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.

Treatment:

Diagnostic Test: Selective Sonography of the ventral abdominal hernia level