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临床试验/NCT07821775
NCT07821775已完成不适用

Early Oncologic and Perioperative Outcomes of Robotic Surgery Across Seven Abdominopelvic Malignancies

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 32,949 人开始时间: 2012年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32,949
试验地点
1
主要终点
1-Year Disease-Free Survival

研究概览

简要总结

Robotic surgery has become an increasingly common option for treating cancers in the abdomen and pelvis. However, whether robotic surgery leads to better cancer-related outcomes than laparoscopic (keyhole) surgery or open surgery is still uncertain. Results may differ across cancer types, and factors such as how complex the surgery is and how experienced the surgeon is may also influence the outcome.

This retrospective cohort study examined adults who underwent curative-intent surgery for one of seven abdominopelvic cancers (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) at a large tertiary hospital in Seoul, South Korea, between January 2012 and December 2021. Patients were classified into three groups according to the surgical approach they received: open, laparoscopic, or robotic surgery.

The main outcome was 1-year disease-free survival, defined as the time from surgery to the first occurrence of cancer recurrence, distant metastasis, or death from any cause. Additional outcomes included 1-year mortality, overall mortality during follow-up, major postoperative complications, acute kidney injury, and length of hospital stay.

To reduce differences between groups that might affect the comparison, the study used a statistical method called propensity score overlap weighting. Additional analyses adjusted for surgical complexity, surgeon experience including robotic learning curve, and pathological cancer stage to isolate the effect of the surgical platform itself.

The purpose of this study was to evaluate whether the association between surgical approach and early oncologic and perioperative outcomes differed across the seven cancer types, and whether any observed advantage of the robotic platform remained after accounting for these factors.

详细描述

Study Design This was a single-center, retrospective cohort study conducted at Asan Medical Center, a large tertiary referral center in Seoul, Republic of Korea. The study protocol was approved by the Institutional Review Board of Asan Medical Center (approval number 2026-0316), and the requirement for written informed consent was waived due to the retrospective design. The study is reported in accordance with the Strengthening the Reporting of Cohort, Cross-sectional and Case-control Studies in Surgery (STROCSS) guideline.

Study Population Adults aged 18 years or older who underwent curative-intent abdominopelvic surgery for one of seven nonmetastatic malignant solid tumors (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) between January 1, 2012, and December 31, 2021 were considered eligible. Patients were excluded if they had distant metastasis before surgery, presented with recurrent disease from previously treated cancer, or had incomplete key demographic, comorbidity, operative, or outcome data.

Exposure Patients were classified into three groups according to the surgical approach: open surgery, laparoscopic surgery, and robotic surgery. Two pairwise cohorts were constructed for comparative effectiveness analyses: (1) open versus robotic surgery for all seven cancer types, and (2) laparoscopic versus robotic surgery for six cancer types (prostate cancer excluded due to absence of laparoscopic prostatectomy at the study institution during the study period).

Primary Outcome

1-year disease-free survival (DFS), defined as the interval from surgery to the first occurrence of cancer recurrence, distant metastasis, or death from any cause. The 1-year time horizon was selected because postoperative oncologic surveillance was systematically available during the first postoperative year across the included malignancies.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older
  • Underwent curative-intent abdominopelvic surgery for a nonmetastatic malignant solid tumor of one of the following types: pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer
  • Surgery performed between January 1, 2012, and December 31, 2021
  • Available postoperative surveillance data

排除标准

  • Presence of distant metastasis before surgery
  • Presentation with recurrent disease from previously treated cancer
  • Incomplete or missing key demographic, comorbidity, operative, or outcome data required for analysis

研究组 & 干预措施

Laparoscopic Surgery

Adults who underwent curative-intent abdominopelvic cancer surgery via conventional laparoscopic approach for one of six cancer types (pancreatic, gastric, rectal, cervical, endometrial, or kidney cancer) between January 2012 and December 2021. Laparoscopic prostatectomy was not performed at the study institution during the study period.

干预措施: No Intervention: Observational Cohort (Other)

Robotic Surgery

Adults who underwent curative-intent abdominopelvic cancer surgery via robotic-assisted (da Vinci) approach for one of seven cancer types (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) between January 2012 and December 2021.

干预措施: No Intervention: Observational Cohort (Other)

Open Surgery

Adults who underwent curative-intent abdominopelvic cancer surgery via open (laparotomy) approach for one of seven cancer types (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) between January 2012 and December 2021.

干预措施: No Intervention: Observational Cohort (Other)

结局指标

主要结局

1-Year Disease-Free Survival

时间窗: 1 year after surgery

Time from surgery to the first occurrence of cancer recurrence, distant metastasis, or death from any cause, censored at 1 year. Recurrence and metastasis were confirmed radiologically or pathologically. Patients without an event were censored at the last postoperative surveillance encounter.

次要结局

  • 1-Year All-Cause Mortality(1 year after surgery)
  • Overall All-Cause Mortality During Follow-up(From date of surgery to date of death or end of follow-up, assessed up to approximately 10 years)
  • Major Postoperative Complications Within 30 Days(Within 30 days after surgery)
  • Postoperative Acute Kidney Injury(Within 7 days after surgery)
  • Hospital Length of Stay(From date of surgery to date of hospital discharge, up to 90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ji-Hoon Sim

Assistant Professor

Asan Medical Center

研究点 (1)

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