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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastric Cancer

Intervention / Treatment
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* Procedure: Robotic Gastrectomy
* Procedure: Laparoscopic Gastrectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Robotic Gastrectomy<br>Patients who will be treated for gastric cancer with the assistance of the robotic surgical system | Procedure: Robotic Gastrectomy<br>* 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.<br>|
| Laparoscopic Gastrectomy<br>Patients who will be treated for gastric cancer through laparoscopic devices. | Procedure: Laparoscopic Gastrectomy<br>* Minimally invasive surgical approach performed through traditional laparoscopy.<br>|
| Open Gastrectomy<br>Patients who will be treated for gastric cancer with traditional open surgery. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with intraoperative adverse events | events other than the normal course of the surgery | During surgery | 
| Mean of retrieved lymph nodes | Count of retrieved lymph nodes at the histopathological examination of the surgical specimen | Within 30 days after surgery | 
| Rate of patients alive | subjects alive at the planned endpoint | 1 year after surgery | 
| Rate of patients alive | subjects alive at the planned endpoint | 2 year after surgery | 
| Rate of patients alive | subjects alive at the planned endpoint | 3 year after surgery | 
| Rate of patients alive | subjects alive at the planned endpoint | 4 year after surgery | 
| Rate of patients alive | subjects alive at the planned endpoint | 5 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean post-operative hospital stay | hospital stay of the patients after surgery | from the day after surgery to patient discharge, assessed up to 90 days | 
| Rate of complications after discharge | any surgical related event after patient's discharge | 5 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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minimally invasive surgery, gastrectomy, robotic surgery, laparoscopic surgery, laparoscopy, robot-assisted, robotic, robotic gastrectomy, laparoscopic gastrectomy, minimally invasive gastrectomy