Prospective Study of Minimally Invasive Hernia Repair
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Hernia recurrence rate
概览
简要总结
The participating researchers register all adult patients (who have given informed written consent) scheduled for elective repair of an abdominal wall hernia (NOT inguinal hernias) via minimally invasive operation technique (i.e.: laparoscopy or robotic repair) and perform a follow up of 5 years to analyze clinical outcome parameters. These parameters include recurrence of the hernia, intra- and postoperative complications, quality of live, esthetic outcome and pain.
The patients will be reviewed in person by the participating researchers at 2-3 moths, 1 year, 3 years and 5 years after surgery. A computed tomography will be performed at 1 year after surgery and in case of suspicion of complications, for example hernia recurrence. The treatment and follow-up of the participating patients does not differ from the standard treatment protocol (and the not participating patients).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Indication for elective minimally invasive ventral hernia repair due to criteria of the participating surgeons
排除标准
- •Patient rejects participation or giving written informed consent
- •Positive pregnancy test (Beta HCG in serum)
- •Patients who do not meet criteria for minimally invasive surgery due to the criteria of the including surgeon or anesthesiologist (Loss of domain, giant abdominal wall herniae, very small (W1) isolated midline hernia, severe pulmonary or cardiac pathologies)
研究组 & 干预措施
All adult patients with indication of elective minimally invasive abdominal wall hernia surgery
The patients will be intervened by laparoscopic or robotically assisted hernioplastia of midline or lumbar hernias, either primary or secondary in nature. Inguinal hernias will only be included if they exist apart from the primarily targeted midline or lumbar abdominal wall hernia
干预措施: Minimally invasive hernioplastia (Procedure)
结局指标
主要结局
Hernia recurrence rate
时间窗: 5 years (the time to recurrence will be defined by the moment of radiological confirmation)
Percentage of all the patients intervened who present a radiologically (via CAT Scan or MRI in case of contraindication for CAT Scan) confirmed hernia recurrence. In case of suspicion (physical exam and/or symptoms reported by the patient) a CAT Scan will be performed to confirm or discard the diagnosis, at any time of the follow-up
次要结局
- Postoperative complications Clavien Dindo(90 days after surgery)
- Surgical Site Occurrence (SSO)(5 years)
- Perioperative bleeding(30 days)
- Mortality(5 years)
- Reintervention Rate(5 years)
- Risk Factors(Only at time of inclusion)
- Prehabilitation(at the time of registration)
- Hernia associated quality of life(5 years)
- Postoperative pain(24 and 48 hours after surgery (during the rest of the follow-up this value is included in the EuraHS QoL questionnaire))
研究者
Marius Kaeser
Surgical Staff, Surgeon in the department of General Surgery of the Hospital Universitario Fundación Jiménez Díaz
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz