Midline Vs Triangular Port Placement in Total Extra‑Peritoneal Mesh Repair in Uncomplicated Inguinal Hernia: A Randomized Control Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- 1. To compare ergonomic suitability for the surgeon between midline versus triangular port placement in Total Extra‑Peritoneal Mesh Repair (Body part discomfort questionnaire by SAGES and Surgeon satisfaction score)
研究概览
简要总结
Justification for the study:
· TEP (total extra‑peritoneal mesh repair) and TAPP (Trans-abdominal pre-peritoneal mesh repair) are two commonly used laparoscopic surgical techniques for inguinal hernia repair
· In TEP it doesn’t require to enter inside the abdominal cavity so the risk of visceral injury, port site hernia and post-operative adhesions are low. However, it has certain limitations like narrow working space, low angle of manipulation, difficulty in unfurling of mesh, crowding of instruments (especially in short stature patients) so surgeons have been trying to find different port positions to deal with these difficulties.
· Singh S. et al. (Surg Endosc, 2021) did RCT and compared two different techniques for TEP and concluded that triangular port placement is ergonomically better than midline port placement, However the primary outcome in the study was postoperative pain and not ergonomics.
· Xiaoqiang Zhu et.al (Journal of surgical research 2019) in and RCT found that triangular port placement has advantages like better triangulation of instruments, ease in sac dissection, ease in suturing if required
· A RCT with a good design, a sufficient sample size, is required to settle the debate over the ergonomically better technique for TEP repair. Hence, there is a need to conduct this study.
The purpose of this study is to investigate the ergonomics of triangular vs. midline port placement in TEP repair.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Consenting to participate in the study and follow-up.
排除标准
- •Less than 18 years and more than 80 years of age
- •Complicated inguinal hernia (Obstructed, Strangulated, Prior inguinal hernia surgery, Previous lower abdomen surgery)
- •Bilateral Inguinal Hernia.
结局指标
主要结局
1. To compare ergonomic suitability for the surgeon between midline versus triangular port placement in Total Extra‑Peritoneal Mesh Repair (Body part discomfort questionnaire by SAGES and Surgeon satisfaction score)
时间窗: 1. 2 hours | 2. 2 hours
2. To compare energy expenditure of the operating surgeon during the surgery (Using Apple Health App on Apple watch SE2).
时间窗: 1. 2 hours | 2. 2 hours
次要结局
- 1. Postoperative pain using VAS score(2. Intraoperative complications (cord injury, vascular injury, or visceral organ injury))
研究者
Manjunath Maruti Pol
All India Institute of Medical Sciences New Delhi