NL-OMON53544招募中不适用
MARS study- Mesh Augmented Reinforcement of Abdominal Wall Suture Line in Patients Undergoing Midline Laparotomy to limit the Rate of Incisional Hernia ( IH) Occurrence - MARS study
niversitair Medisch Centrum0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Preoperative Inclusion Criteria
- •1. Subject has provided informed consent.
- •2. Subject is >=18 years of age at the time of consent.
- •3. Subject will be undergoing an elective surgery with a planned midline
- •laparotomy with retrorectus mesh placement.
- •3A. Subject will be undergoing an elective laparoscopy with a planned
- •possibility of a conversion to midline laparotomy or an elective laparoscopy
- •with a planned possible midline laparotomy for specimen extraction.
排除标准
- •Preoperative Exclusion Criteria
- •1. Subject is undergoing emergency surgery, i.e. lifesaving procedures
- •performed where patient is in imminent danger of death
- •2. Subject has a history of allergic reactions after application of
- •poly-L-lactide, poly-trimethylene carbonate copolymers (PLLA/TMC)
- •3. Subject is pregnant or is planning pregnancy during study duration
- •period(Females of child-bearing potential will be required to provide either a
- •urine or serum pregnancy test (except for subjects who are surgically sterile
- •or are at least 2 years post-menopausal))
- •3a: Subject is breastfeeding or is planning to breastfeed during the study
- •duration period
- •4. Subject is unable or unwilling to comply with the study requirements or
- •follow-up schedule
- •5. Subject is scheduled for another planned surgery, and subsequent surgery
- •would jeopardize previous application of study treatment
- •6. Subject with a body mass index (BMI) > 45 kg/m2
- •7. Subjects with the following medical interventions/medical conditions are
- •excluded from participation in the study: uncontrolled diabetes (hemoglobin A1c
- •(Hb1Ac) > 60mmol/mol), cirrhosis, stoma wearers
- •8. Concomitant ostomy (stomacreation)
- •9. Subject who had received a mesh in a previous ventral hernia repair or has
- •an existing ventral hernia>2cm
- •10. Subject with a life expectancy inferior to the study follow-up duration (36
- •11. Study procedure is a relaparotomy within 30 days of previous abdominal
- •12. Subject with an American Society of Anesthesiologists (ASA) scores higher
- •13. Subject has participated in an investigational drug study within the
- •washout period of the drug or in a device study that would interfere with mesh
- •implantation or assessment of incisional hernia
- •14. Subject with current chemo and/or radiation therapy within 2 weeks of
- •Only exclusion of chemotherapeutic drugs that have:
- •Cytotoxic effect and/or
- •Inhibit of cell replication and/or
- •Impaired tissue healing
- •15. Subject with any history of ascites
- •16. Subject has a medical condition that precludes the patient from
- •participation in the opinion of the investigator
- •17. Subject is undergoing a vascular procedure other than abdominal aortic
- •aneurysm (AAA) surgery (i.e, only AAA surgeries accepted)
- •Intraoperative Exclusion criteria
- •1. Subject*s study procedure is in a contaminated or infected site as assessed
- •by the Investigator(s) (CDC Class 3 and 4)
- •2. Abdomen is left open at the end of the procedure
- •3. Subject has an unsuspected ventral hernia >2cm encountered at the time of
- •4. Inability to close the anterior fascia or keep the mesh securely out of the
- •peritoneal cavity
- •5. Second-look procedure planned
- •6. Cases requiring a full-thickness partial resection of the abdominal wall (in
- •particular the midline) because of involvement in neoplastic process or complex
- •7. Inoperable tumor/poor prognostic cancer/patient non curatively treated
- •8. Subject has a suture length to wound length ratio< 3.5/1
- 另有 4 项未显示
研究者
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