Continuous Locked Non-barbed Suture for Mesh Fixation During Laparoscopic Ventral Rectopexy for Severe Rectal Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Operative time
研究概览
简要总结
This prospective randomized pilot study is aimed to verify if the operative time of a standard laparoscopic ventral rectopexy for the treatment of severe rectal prolapse could be further reduced using a continuous locked suture vs. conventional single 6-points suture for mesh fixation.
详细描述
Introduction Laparoscopic ventral rectopexy could be considered the gold standard procedure for rectal prolapse because provides the potential to combine the success rates of an abdominal approach with the faster recovery associated with a minimally invasive technique. Tissue dissection and mesh placement may also be facilitated by the magnification and field of view permitted by the laparoscopic approach. These benefits must be balanced against a longer operating time from 150 to 250 minutes according to surgeons' experience. This prospective randomized pilot study is aimed to verify if the operative time of a standard laparoscopic ventral rectopexy for the treatment of rectal prolapse could be further reduced using using a continuous locked suture vs. conventional 6-points single suture for mesh fixation.
Secondary endopoints of this comparison are incidence of intra- or postoperative complications estimated blood loss, postoperative pain (evaluated by VAS), days of hospitalization and costs for the health care system.
Statistical Analysis and Study Design This is a single Institution prospective randomized clinical trial conducted at the Pia Fondazione Panico of Tricase, Italy.
To have an imbalanced results and to reduce any bias, a randomization list has been checked.
Probability (p) values will be considered to be statistically significant at the <0.05 level.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For patients
- •Age ≤ 80 years
- •Patient's informed consent
- •American Society of Anesthesiologists: < class III or IV
- •Physiologic, surgical or iatrogenic menopause.
- •No previous major abdominal surgical procedures For diseases
- •POP-Q stage III/IV for anterior and/or apical compartment; stage <III for posterior compartment.
- •No uterine cervix dysplasia or endometrial disorders.
- •No uterine size larger than conform 10 weeks gestation
排除标准
- 未提供
结局指标
主要结局
Operative time
时间窗: 1 year
Operative time for RVL will be calculated from the entrance to exit from the abdominal cavity
次要结局
未报告次要终点
研究者
Andrea Morciano
Principal Investigator
Azienda Ospedaliera Cardinale G. Panico
