NCT02751086

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: International Study Group on Minimally Invasive Surgery for Gastric Cancer · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	Robotic Gastrectomy	Minimally invasive surgical approach, related to the availability of a robotic surgical system (eg Da Vinci surgical system), that allows a surgeon to perform surgery through a console and dedicated devices.
PROCEDURE	Laparoscopic Gastrectomy	Minimally invasive surgical approach performed through traditional laparoscopy.

Timeline

• Start date: 2016-04-01
• Primary completion: 2020-01-01
• Completion: 2024-12-01
• First posted: 2016-04-26
• Last updated: 2019-04-22

Locations

1 site across 1 country: Italy