Randomized Controlled Trial Comparing 3D Endovision and 2D UHD- 4K Endovision System in Laparoscopic Hernia and Gallbladder Surgery: Impact on Surgical Performance and Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
研究概览
简要总结
This study is a prospective, single blinded, single centre- randomized controlled trial which aims to compare the error rates and efficiency in doing laparoscopic gall bladder and inguinal hernia surgeries while using 2D and 3D endovision systems respectively.. Primary Objective of the study is to compare the error rates using Technical Skills Checklist in 3 -dimensional (3D) endovision versus ultra-high-definition 4-K endovision system for laparoscopic hernia and gall bladder surgery.. Secondary objectives are to compare the total time taken as well as the time taken in various phases of the surgery using either 3D or 2D Endovision system by an experienced surgeon (experience of more than 10 cases on either system). We also aim to compare the surgeon satisfaction and workload assessment using SURG-TLX (Surgery task load index) scale for surgery done using 3 -dimensional (3D) endovision versus 2D ultra-high-definition 4-K endovision system. This study includes 144 participants over a duration of 1.5 years. Our study design addresses gaps in generalizability, long-term effects, and economic viability in previously conducted similar studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Elective laparoscopic cholecystectomy
- •Elective laparoscopic TAPP or TEP repair (including complicated hernia repair)
- •Well versed with the 4K and 3D Endovision system with at least experience of 10 cases on the system.
排除标准
- •Emergency procedures
- •Irreducible/ obstructed or strangulated hernia requiring emergency procedure
- •Lack of experience using 4K or 3D Endovision system with surgical experience of less than 10 cases
- •Surgical procedures converted intra-operatively from laparoscopic to open surgical procedure.
研究者
Dr Mahendra Pratap Singh
All India Institute Of Medical Science, Bathinda
