Clinical trial NCT04435340: 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
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Hernia
Keywords: Abdominal Hernia
Ventral Hernia
Atraumatic mesh
Lead sponsor: Spital Limmattal Schlieren
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: retro- and prospective arm
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Recurrance rate in sonography
timeFrame: 12 months after surgery
measure: Recurrance rate clinically
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Pain and sensation of the mesh measured by the Carolinas Comfort Scale questionnaire
timeFrame: 12 months after surgery
measure: Limitations in quality of life questionnaire
timeFrame: 12 months after surgery
measure: Daily activities measured HerQLes questionnaire
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Schlieren
country: Switzerland
facility: Spital Limmattal
state: Zurich
Study officials:
affiliation: Spital Limmattal Schlieren
name: Urs Zingg
role: STUDY_CHAIR
References: