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临床试验/NCT06376227
NCT06376227已完成不适用

With or Without Left Colic Artery Preservation

Northern Jiangsu People's Hospital1 个研究点 分布在 1 个国家目标入组 1,164 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,164
试验地点
1
主要终点
The incidence of anastomotic leakage in postoperative patients with or without left colic artery preservation.

研究概览

简要总结

Brief Summary

Background The preservation of the left colic artery (LCA) during rectal cancer resection remains a topic of controversy, and there is a notable absence of robust evidence regarding the outcomes associated with LCA preservation. And the advantages of robotic-assisted laparoscopy (RAL) surgery in rectal resection remain uncertain. The objective of this study was to assess the influence of LCA preservation surgery and RAL surgery on intraoperative and postoperative complications of rectal cancer resection.

Methods Participants who underwent laparoscopic (LSC) or RAL with or without LCA preservation resection for rectal cancer between April 2020 and May 2023 were retrospectively assessed. The patients were categorized into two groups: low ligation (LL) which with preservation of LCA and high ligation (HL) which without preservation of LCA. A one-to-one propensity score-matched analysis was performed to decrease confounding. The primary outcome was operative findings, operative morbidity, and postoperative genitourinary function.

详细描述

The investigators retrospectively collected data from the medical records of participants who had rectal cancer at Northern Jiangsu People's Hospital, from April 2020 to May 2023. A total of 612 from 1164 cases were included in this study; in 462 cases, the LCA was preserved by LL intraoperatively (LL group), in which 202 cases underwent robotic-assisted laparoscopy (LL-RAL subgroup) and 260 cases underwent laparoscopy (LL-LSC subgroup). While in the remaining 150 cases, the LCA was not preserved by HL intraoperatively (HL group). in which 70 cases underwent robotic-assisted laparoscopy (HL-RAL subgroup) and 80 cases underwent laparoscopy (HL-LSC subgroup).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Low anterior resection for rectal cancer
  • Postoperative pathological diagnosis of rectal adenocarcinoma
  • Informed consent signed prior to surgery.

排除标准

  • Recurrent rectal cancer
  • Emergency surgery
  • Preoperative and intraoperative detection of distant organ metastases or extensive
  • Implantation metastases in the abdominal cavity
  • Palliative surgery
  • A postoperative pathology report that showed residual cancer cells at the proximal or distal resection margin
  • No standard chemotherapy for tumor-node-metastasis (TNM) staging II or III after surgery
  • Synchronous colorectal carcinoma and other organ tumors
  • Incomplete case data.

结局指标

主要结局

The incidence of anastomotic leakage in postoperative patients with or without left colic artery preservation.

时间窗: 2 weeks within the surgery

Within two weeks after surgery, the patient experienced abdominal pain, fever, and imaging diagnosis showed anastomotic leakage.

次要结局

  • The genitourinary function of the patients after the radical resection with or without left colic artery preservation.(6 to 12 months after operation)

研究者

发起方
Northern Jiangsu People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daorong Wang

Doctor

Northern Jiangsu People's Hospital

研究点 (1)

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