Robotic, Laparoscopic and Open Surgery for Gastric Cancer Compared on Surgical, Clinical and Oncological Outcomes
Robotic, Laparoscopic and Open Surgery for Gastric Cancer Compared on Surgical, Clinical and Oncological Outcomes
Gastric cancer represents a great challenge for health care providers and requires a
 multidisciplinary context in which surgery plays a main role.

 Minimally invasive surgery has been progressively developed, first with the advent of
 laparoscopy and more recently with the spread of robotic systems, but a number of issues are
 currently being debated, including the limitations in performing effective extended lymph
 node dissections and, in this context, the real advantages of using the robotic systems, the
 possible role for the Advanced Gastric Cancer, the reproducibility of completely
 intracorporeal techniques and the oncological results achievable during follow-up.

 A multicenter study with a large number of patients is now needed to further investigate the
 safety and efficacy as well as long-term outcomes of robotic surgery, traditional laparoscopy
 and the open approach.
Overall purpose:

 The Overall purpose is to develop a multi-institutional database comprising information
 regarding surgical, clinical and oncological features of patients undergoing surgery for
 gastric cancer with robotic, laparoscopic or open approaches and subsequent follow-up at
 participating centers.

 General study design:

 The registry will be established by retrospectively identifying subjects with gastric cancer
 treated at the participating centers.

 Information gathered will be obtained from existing data and records, diagnostic tests and
 surgical interventions.

 Information will be collected and recorded by all institutes through a specific online shared
 system.

 Main objectives:

 -  To determine the surgical, clinical, and oncological outcomes in both the short and long
 term

 -  To compare results according to the type of intervention, device used and manner of
 execution of different surgical phases

 -  To relate results of different surgeries with baseline characteristics of patients and
 stage of disease

 Clinical relevance:

 Studies that reported results of minimally invasive surgery for gastric cancer and recent
 meta-analysis emphasize the need for large trials.

 A further consideration in this field regards the need of numerous patients to reach a
 statistical significance on surgical, clinical and oncological outcomes, in order to fully
 assess the effectiveness and the differences between the different surgical approaches.

 At present, a multicenter registry may represent the best research tool to assess the role of
 minimally invasive approaches by comparing the methods with traditional open surgery.

 Therefore, for this project, a large registry will be created by collecting data from the
 different participating centers to create a working basis for analyzing outcomes of interest
 and obtaining directions for further investigation.

 The data collected will clarify the role of laparoscopic and robotic surgery versus the open
 approach in terms of:

 -  safety and feasibility based on the intraoperative outcomes

 -  respect of oncological principles in relation to the stage and location of the tumor

 -  recovery of gastrointestinal function considering the outcomes measured during the
 postoperative hospital stay

 -  incidence, types and severity of postoperative complications

 -  overall survival and disease-free survival

 Duration of study:

 The beginning of the trial is scheduled for January 2015. It is expected to end the chart
 review within one year.

 Type of data collection:

 In the present study, the following information will be collected:

 -  Patient Demographics

 -  Surgical Procedure details

 -  Tumor characteristics

 -  Operative findings

 -  Post-operative clinical findings

 -  Post-operative complications

 -  Follow-up details

 Statistical analysis:

 The dichotomous variables will be expressed as numbers and percentages, while continuous
 variables will be expressed as mean and standard deviation (SD) or median and interquartile
 range (minimum and maximum values).

 Continuous variables, will be compared using one-way ANOVA with post hoc multiple comparison
 by Tukey's procedure. Pearson's χ2 test or Fisher's exact test, as appropriate, will be used
 for analysis of categorical data.

 For each of these tests a value of alpha (α) < 0.05 will be considered statistically
 significant.

 Potential risks and safety management:

 Participation in the research registry involves the potential risks of a breach of
 confidentiality of the medical record information and associated privacy of the participants.

 Such risks will be minimized by the use and the establishment of appropriate information
 technology services.
Inclusion Criteria:

 -  Histologically proven gastric cancer

 -  Preoperative staging work-up performed by upper endoscopy / endoscopic ultrasound, and
 CT scan

 -  Early Gastric Cancer

 -  Advanced Gastric Cancer

 -  Patients treated with curative intent in accordance to international guidelines

 Exclusion Criteria:

 -  Locally advanced tumor infiltrating neighboring organs

 -  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 gastric surgery

 -  Remnant gastric cancer

 -  Synchronous other major abdominal surgery

 -  Synchronous malignancy in other organs

 -  Palliative surgery cases