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Comparison of Short- and Long-term Efficacy of Robotic Versus Laparoscopic Gastrectomy in High-risk Patients With Gastric Cancer: a Nationwide, Multicentre Cohort Study

NCT06603272 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 534

Last updated 2024-09-19

No results posted yet for this study

Summary

Since 2007, robotic gastrectomy (RG) has been considered an option for minimally invasive surgery (MIS)1. In recent years, several randomised trials and retrospective studies have compared short-term efficacy and oncological outcomes between RG and laparoscopic gastrectomy (LG)2-5. Compared with traditional laparoscopic gastric surgery, RG may yield better short-term and comparable long-term outcomes4-6.

According to previous studies7, 8, American Society of Anesthesiologists (ASA) grade ≥3, body mass index (BMI) ≥ 30 kg/m2, age ≥80 years, and clinical T4 stage are considered to be sensitive indicators for assessing surgical risk among patients with cancer. Patients with any of these factors were defined as high risk patients who constitute a special group. Previous research has shown that obesity, advanced age, comorbid conditions, and tumour cT stage are factors associated with mortality and complication rates in MIS for gastrointestinal malignancies6,7. Therefore, it is crucial to explore the impact of high-risk factors on prognosis. Many elderly patients have comorbidities with a high incidence of cardiopulmonary disease(s)8-10. Moreover, patients with poor baseline conditions often struggle to tolerate major surgery, and their comorbid state and ASA score are high-risk factors that affect postoperative complications and prognosis11-14. High BMI, especially among obese patients in whom excessive abdominal fat obscures anatomical regions, limits the flexibility of laparoscopic instruments, hinders complex perivascular lymph node dissection, and increases the difficulty of D2 lymphadenectomy, may increase postoperative complications15-17. Advanced-stage tumours, particularly those at the cT4 stage, present with more enlarged metastatic lymph nodes, making the exposure of vessels and dissection more challenging6,7. All of these factors are considered to be high-risk factors for surgical procedures. With the increasing prevalence of aging populations and obesity18-20, more high-risk patients with resectable gastric cancer (GC) are undergoing MIS.

To further explore this increasing concern about clinical practice, our study is the first to compare the short- and long-term outcomes of RG and LG in a high-risk gastric cancer population, with the aim of providing high-level, evidence-based medicine for the widespread application of RG in this population. To the best of our knowledge, this is the first multicentre, large-sample study to compare the advantages of RG and LG in a high-risk GC population.

Conditions

  • Patients With More Than or Equal to One of the Following Criteria Were Defined as High-risk Patients

Interventions

DEVICE

The da Vinci robotic system (Intuitive Surgical, Inc., Sunnyvale, CA, USA) was used for all robotic gastrectomy

Surgical intervention was initiated after obtaining informed consent from all patients, which included the additional costs of robotic surgery, a comprehensive explanation of surgical risks, and potential alternative treatments, thus facilitating informed surgical approach choices (i.e., LG or RG) within the participating institutions. Adherence to the "Japanese Gastric Cancer Treatment Guidelines" was maintained for determining the extent of gastrectomy and lymphadenectomy.

Sponsors & Collaborators

  • Fujian Medical University

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-01
Primary Completion
2019-06-05
Completion
2023-06-15
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06603272 on ClinicalTrials.gov