Clinical and Sonographic Outcome After Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh in the Retro-rectus (Sublay) Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Recurrance rate in sonography
研究概览
简要总结
Patients who underwent ventral abdominal hernia repair with self adhering, atraumatic mesh in sublay position are examined for their recurrence rate
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Inability to comply with the study protocol
结局指标
主要结局
Recurrance rate in sonography
时间窗: 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 .
Recurrance rate clinically
时间窗: 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 .
次要结局
- Pain and sensation of the mesh measured by the Carolinas Comfort Scale questionnaire(12 months after surgery)
- Limitations in quality of life questionnaire(12 months after surgery)
- Daily activities measured HerQLes questionnaire(12 months after surgery)
研究者
Prof Urs Zingg
Head of Department of Surgery
Spital Limmattal Schlieren