Robotic, Laparoscopic and Open Gastrectomy Compared on Short and Long Term Outcomes

Prospective, Observational, Multicenter Study on Minimally Invasive Gastrectomy for Gastric Cancer: Robotic, Laparoscopic and Open Surgery Compared on Operative and Follow-up Outcomes

The overall purpose is to develop and maintain a multi-institutional database comprising of information regarding surgical, clinical and oncological features of patients that will be treated for gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up.

The main objective is to compare the three surgical arms on surgical and clinical outcomes, as well as on the oncological follow-up.

A review of the scientific literature, which was recently published by the IMIGASTRIC study group, aimed to perform a more complete analysis of the current situation regarding performing minimally invasive surgery for gastric cancer. Significant limitations were found in the analyzed studies, including:

• Small samples of patients, mostly low-quality comparative studies
• Selection bias in the comparison groups (e.g. stage, extent of lymphadenectomy)
• Absence of subgroup analysis in significant research fields
• Lack of information on the surgical techniques adopted

A large prospective multicenter registry could thus be the optimal way to clarify the role of minimally invasive surgery for gastric cancer and permit the evaluation of its short and long-term effects. A working basis for analyzing outcomes of interest and obtaining directions for guidelines and future study developments can also be created. The following would be the main advantages of a large prospective multicenter registry:

• Achieving a large sample of patients
• Collecting multiple variables, allowing for the making of a comprehensive statistical report
• Standardizing the methodology to be adopted, thus increasing accuracy
• Bringing together the experiences of both East and West to discover shared points A prospective registry can become a powerful tool that can guide research in this field to new developments and pave the way for other investigational opportunities.

Inclusion Criteria:

• Histologically proven gastric cancer
• Preoperative staging work-up performed by upper endoscopy and/or endoscopic ultrasound, and CT scan and in accordance to international guidelines
• Early Gastric Cancer
• Advanced Gastric Cancer
• Patients treated with curative intent in accordance to international guidelines

Exclusion Criteria:

• Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, Krukenberg tumors, involvement of other organs
• Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score > 4
• History of previous abdominal surgery for gastric cancer
• Synchronous malignancy in other organs
• Palliative surgery