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临床试验/NCT07383961
NCT07383961已完成不适用

LONG TERM FOLLOW UP AFTER PEDIATRIC SINGLE SITE ROBOTIC CHOLECYSTECTOMY

Good Samaritan Hospital Medical Center, New York1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
postoperative complications

研究概览

简要总结

Robotic single-site cholecystectomy (RSSC) was first reported in children the PI from GSH in 2015, demonstrating the feasibility, safety, and short learning curve associated with RSSC.

The primary advantages of RSSC identified in pediatric patients include superior cosmetic outcomes, reduced postoperative pain, and a shorter learning curve for surgeons compared to SILC. These benefits contribute to its growing acceptance among pediatric surgeons.

However, despite clear short-term benefits, the need for evaluating long-term outcomes in pediatric populations remains unmet. There are currently no studies reporting long-term complications or cosmetic satisfaction following RSSC in pediatric patients.

This study will attempt to evaluate the long term outcomes after RSSC and compare them with the current gold standard, multiport laparoscopic cholecystectomy, performed by the same surgeon at the same institution over a similar time frame.

详细描述

Robotic single-site cholecystectomy (RSSC) was first reported in children by Jones (2015), who conducted a retrospective review demonstrating the feasibility, safety, and short learning curve associated with RSSC compared to single-incision laparoscopic cholecystectomy (SILC) in pediatric patients, which has been proven to be technically challenging [1]. Subsequently, Esposito et al. further supported these findings, showing similar safety and effectiveness of RSSC in pediatrics over a 6-year period [2]. Rothenberg et al. compared robotic-assisted cholecystectomy (RC) to laparoscopic cholecystectomy (LC) in children, highlighting no significant differences in immediate postoperative complications, opioid utilization, or hospital readmissions but identifying higher costs associated with RC [3]. Kulaylat et al. similarly reported longer operative times (98 vs 79 minutes) and higher overall costs ($15,519 vs $11,197) for robotic procedures compared to laparoscopic ones, though postoperative complications and length of stay (LOS) were comparable [4].

The primary advantages of RSSC identified in pediatric patients include superior cosmetic outcomes, reduced postoperative pain, and a shorter learning curve for surgeons compared to SILC. These benefits contribute to its growing acceptance among pediatric surgeons.

However, despite clear short-term benefits, the need for evaluating long-term outcomes in pediatric populations remains unmet. There are currently no studies reporting long-term complications or cosmetic satisfaction following RSSC in pediatric patients.

In adult populations, short-term studies comparing RSSC and multiport laparoscopic cholecystectomy (MLC) revealed comparable hospital stay, complication rates, seroma formation, and infection rates [5]. Hagen et al. demonstrated increased costs and higher reoperation rates for hernias with RSSC compared to MLC in adults [6]. Lurje et al. evaluated short-term cosmetic outcomes, confirming patient satisfaction with robotic surgery in adults, but no pediatric data was provided [7].

In pediatric patients, short-term follow-ups primarily emphasized operative safety, operative time, hospital stay, and immediate postoperative complications, generally showing equivalence between RC and LC with the exception of higher costs for RC [3,4].

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Those who have undergone cholecystectomy by laparoscopic or robotic surgery over the past 12 years at GSUH -

排除标准

  • multiple procedures at same time

研究组 & 干预措施

laparoscopic multiport cholecystectomy

robotic single site cholecystectomy

结局指标

主要结局

postoperative complications

时间窗: 24-60 months

次要结局

  • cosmetic satisfaction(24-60months)

研究者

发起方
Good Samaritan Hospital Medical Center, New York
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vinci Jones

Pediatric Surgeon

Good Samaritan Hospital Medical Center, New York

研究点 (1)

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