NCT04435340

Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Spital Limmattal Schlieren · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Hernia

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-03-22
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-06-17
• Last updated: 2023-04-13

Locations

1 site across 1 country: Switzerland