Mesh Matters: Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment - a Randomized, Blinded Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Surgical Site Occurrences (SSO) Assessed by Clinical Examination and Ultrasound
研究概览
简要总结
The goal of this clinical trial is to investigate whether mesh-suture affects wound complication rates, patient-reported quality of life, and operation time in adult patients undergoing surgery for small ventral hernias.
The main questions it aims to answer are:
Does mesh-suture reduce wound complication rates compared to planar mesh? Does mesh-suture improve patient-reported quality of life(QoL) and affect operation time compared to planar mesh?
Comparison group:
Researchers will compare standard treatment with planar mesh to the interventional treatment with mesh-suture to see whether mesh-suture leads to fewer complications, better quality of life, and shorter operation time.
Participants will:
Be randomized to receive either planar mesh or mesh-suture during hernia repair surgery.
Undergo standardized preoperative assessment, including baseline data and QoL scoring.
Attend a postoperative visit on day 7-13 for wound inspection and ultrasound. Complete QoL assessments at 90 days (telephone follow-up). Have operation time recorded and medical records reviewed for readmissions within 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Ventral hernia (maximum size 3 × 3 cm) measured with Ultrasound or CT.
- •Participants must be eligible for surgical repair using either mesh-suture or planar mesh
排除标准
- •Age < 18 years.
- •Acute (emergent) operation.
- •Pregnancy.
- •Women with plans for future pregnancies.
- •Withdrawal of informed consent during admission.
研究组 & 干预措施
mesh suture
干预措施: mesh suture (Device)
planar mesh
干预措施: planar mesh (Device)
结局指标
主要结局
Surgical Site Occurrences (SSO) Assessed by Clinical Examination and Ultrasound
时间窗: 7-13 days after operation
Definition: We will apply the standardized CDC (Centers for Disease Control and Prevention ) and VHWG (Ventral Hernia Working Group) definitions for SSO. Evaluation: Clinical examination. Additionally, an ultrasound examination will be performed.
次要结局
- Abdominal Hernia-Q Questionnaire(preoperative, postoperative day 10, day 90)
- EQ-5D-5L Index Score(preoperative, postoperative day 10, day 90)
- EQ-VAS (Visual Analogue Scale)(preoperative, postoperative day 10, day 90)
- DURATION OF SURGERY(The time interval from the first incision to the last stitch is set)