Single-Center Observational Study With Comparison of Endoscopic Extended-View Totally Extraperitoneal Prosthesis (eTEP) Versus Open Rives-Stoppa Repair as a Treatment of Midline Abdominal Wall Hernias With Rectus Diastasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Postoperative pain management
研究概览
简要总结
Observational cohort study (partially retrospective, partially prospective) comparing the endoscopic extended totally extraperitoneal prosthesis (eTEP) repair for midline abdominal hernias to open Rives-Stoppa repair (control).
详细描述
See included study protocol. Included patients will be registered to the European Hernia Society (EHS) registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group 1 (eTEP):
- •Participants who underwent an eTEP procedure in the investigators' center
- •Preoperative existence of one or more midline abdominal wall hernias
- •Preoperative existence of rectus abdominis diastasis
- •Group 2 (Rives-Stoppa, control group):
- •Participants who underwent an open Rives-Stoppa (midline repair with sublay mesh) in the investigators' center
排除标准
- •Group 1 (eTEP):
- •Preoperative absence of midline abdominal wall hernias
- •Preoperative absence of rectus abdominis diastasis
- •Intraoperative performance of transverse abdominis release (TAR)
- •Intraoperative inguinal hernia repair
- •Group 2 (Rives-Stoppa, control group):
- •Intraoperative performance of transverse abdominis release (TAR)
- •Intraoperative performance of anterior component separation
- •Intraoperative inguinal hernia repair
结局指标
主要结局
Postoperative pain management
时间窗: From the end of surgery (moment of the end of operation) until the date of discharge from the hospital, assessed up to 30 days.
Modality (type, generic name), duration (days), dosage (grams or milligrams) and frequency (times per day) of analgesics administration
Length of hospital stay
时间窗: From the date of operation until the date of discharge from the hospital, assessed up to 30 days.
Time (days) spent within the hospital
次要结局
- Intraoperative complications(During surgery)
- Postoperative complications(After discharge until 30 days postoperative)