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Completed

NCT Number: NCT04435340

Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh

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

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Key information

Conditions

Abdominal Hernia Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spital Limmattal

Schlieren, Canton of Zurich, 8952, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selective Sonography of the ventral abdominal hernia level

Diagnostic Test

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 outcomes

  1. Recurrance rate in sonography

    Time frame: 12 months after surgery

    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 .

  2. Recurrance rate clinically

    Time frame: 12 months after surgery

    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 outcomes

  1. Pain and sensation of the mesh measured by the Carolinas Comfort Scale questionnaire

    Time frame: 12 months after surgery

    Clinical subjective outcome 1

  2. Limitations in quality of life questionnaire

    Time frame: 12 months after surgery

    Clinical subjective outcome 2

  3. Daily activities measured HerQLes questionnaire

    Time frame: 12 months after surgery

    Clinical subjective outcome 3

Sponsors and collaborators

Lead sponsor

Spital Limmattal Schlieren

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 17, 2020
Registry last updated
Apr 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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