Skip to main content
OpenTrials
Completed

NCT Number: NCT07821775

Robotic vs Laparoscopic and Open Surgery for Abdominopelvic Cancers

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Secondary Outcomes

  • 1-year all-cause mortality
  • Overall mortality during the entire follow-up period
  • Major postoperative complications within 30 days (composite of cardiovascular events, stroke, venous thromboembolism, pneumonia, wound dehiscence, systemic infection, sepsis, acute kidney injury, and urinary tract infection)
  • Postoperative acute kidney injury (KDIGO criteria)
  • Hospital length of stay

Statistical Analysis Propensity scores were estimated separately for each pairwise comparison within each cancer type using multivariable logistic regression, incorporating demographics, tumor stage, surgical factors, comorbidities, preoperative medications, and laboratory measurements. Overlap weights were applied to emphasize patients with substantial covariate overlap without trimming. Time-to-event outcomes were analyzed using weighted Cox proportional hazards models with robust variance estimation. Pooled estimates across cancer types were obtained from models stratified by cancer type, with heterogeneity assessed by interaction testing. Binary outcomes were analyzed using Firth penalized logistic regression, and length of stay using weighted linear regression after log transformation. E-values were computed to assess sensitivity to unmeasured confounding.

Sensitivity Analyses A stepwise doubly robust strategy was applied. Model 1 was the primary overlap-weighted analysis. Model 2 additionally adjusted for surgical complexity (European Society of Cardiology surgical risk category and cancer-specific operation subtypes) and provider-level factors including cumulative robotic experience of the operating surgeon as a proxy for the robotic learning curve. Model 3 further adjusted for pathological severity (advanced T stage, nodal involvement, and FIGO stage where applicable) among patients with available staging.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

No Intervention: Observational Cohort

Other

Participants underwent curative-intent surgery for abdominopelvic malignancies (pancreatic, gastric, rectal, cervical, endometrial, kidney, or prostate cancer) and were followed retrospectively without any experimental intervention. The surgical approach (open, laparoscopic, or robotic) was determined by routine clinical practice, not by study protocol. Data were extracted from the institutional electronic medical record system and linked with national administrative data for outcome ascertainment.

Primary outcomes

  1. 1-Year Disease-Free Survival

    Time frame: 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.

Secondary outcomes

  1. 1-Year All-Cause Mortality

    Time frame: 1 year after surgery

    Death from any cause within 1 year after surgery, ascertained through linked national administrative data.

  2. Overall All-Cause Mortality During Follow-up

    Time frame: From date of surgery to date of death or end of follow-up, assessed up to approximately 10 years

    Death from any cause during the entire follow-up period, ascertained through linked national administrative data.

  3. Major Postoperative Complications Within 30 Days

    Time frame: Within 30 days after surgery

    Composite of cardiovascular events, stroke, venous thromboembolism, pneumonia, wound dehiscence, systemic infection, sepsis, acute kidney injury (KDIGO criteria), and urinary tract infection occurring within 30 days after surgery.

  4. Postoperative Acute Kidney Injury

    Time frame: Within 7 days after surgery

    Acute kidney injury within 7 days after surgery, defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria based on changes in serum creatinine from preoperative baseline.

  5. Hospital Length of Stay

    Time frame: From date of surgery to date of hospital discharge, up to 90 days

    Number of days from the index operation to hospital discharge.

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2022
Study completion
2025
First posted
Sep 16, 2026
Registry last updated
Sep 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.