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临床试验/NCT06409403
NCT06409403招募中不适用

Study on Clinical Application of Robotic Technique

general surgery 31 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
164
试验地点
1
主要终点
International Prostate Symptom Score (IPSS)

研究概览

简要总结

Intraoperative pelvic autonomic nerve (PAN) injury is the dominant reason for genitourinary malfunction after total mesorectal excision (TME), particularly in low rectal tumours. TME necessitates meticulous, sharp dissection with an awareness of the PAN pathway. In particular, laparoscopic TME (L-TME) is technically difficult and requires advanced laparoscopic surgical skills. Comparing with the conventional laparoscopic approach, 3D vision, surgeon-manipulated camera systems, and multi-degree-of-freedom robotic instruments facilitate identification and preservation of the PAN during robotic-assisted TME (R-TME), theoretically facilitating favourable recovery of postoperative genitourinary function. Previous studies have mostly focused on the impact of advanced robotic technologies on postoperative functions. However, in addition to robotic surgical technology, postoperative function is impacted by multiple other intricate factors, such as oncology, comorbidities, postoperative complications, and adjuvant chemoradiotherapy. Consequently, the superiority of robotic surgery in terms of recovery of postoperative genitourinary function has been controversial in previous studies. Hence, to comprehensively evaluate the effect of robotic technology on postoperative genitourinary function, we conducted a prospective controlled study comparing the conventional approach and robotic surgery.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (i) lesions that were determined by histopathological examination and were staged preoperatively using pelvic MRI and CT scans; (ii) patients aged ≥18 and ≤ 75 years; and (iii) American Society of Anesthesiology (ASA) class ≤3

排除标准

  • Benign prostate hyperplasia, previous bladder or prostate surgery, severe sexual dysfunction (International Index of Erectile Function (IIEF) score <10 or Female Sexual Function Index (FSFI) score ≤26.55), urgent operation, simultaneous or heterochronous multiple primary rectal tumours, distant metastasis, or other severe cardiopulmonary complications.

结局指标

主要结局

International Prostate Symptom Score (IPSS)

时间窗: preoperation,1、3、6、12 months after operation

evaluation of genitourinary function

次要结局

  • complication(perioperative)
  • conversion(perioperative)
  • blood loose(perioperative)
  • International Index of Erectile Function (IIEF)(preoperation,1、3、6、12 months after operation)
  • Female Sexual Function Index (FSFI)(preoperation,1、3、6、12 months after operation)
  • operative time(perioperative)
  • complete TME specimens(perioperative)
  • retrieved lymph nodes(perioperative)
  • circumferential resection margins (CRMs)(perioperative)

研究者

发起方
general surgery 3
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

general surgery 3

Director of Gastrointestinal Surgery

The Third Xiangya Hospital of Central South University

研究点 (1)

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