Robotic, Laparoscopic and Open Gastrectomy Compared on Short and Long Term Outcomes (IMIGASTRICII)
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|ClinicalTrials.gov Identifier: NCT02751086|
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : April 22, 2019
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.
|Condition or disease||Intervention/treatment|
|Gastric Cancer||Procedure: Robotic Gastrectomy Procedure: Laparoscopic Gastrectomy|
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.
|Study Type :||Observational|
|Estimated Enrollment :||5000 participants|
|Official Title:||Prospective, Observational, Multicenter Study on Minimally Invasive Gastrectomy for Gastric Cancer: Robotic, Laparoscopic and Open Surgery Compared on Operative and Follow-up Outcomes|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||December 2024|
Patients who will be treated for gastric cancer with the assistance of the robotic surgical system
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.
Patients who will be treated for gastric cancer through laparoscopic devices.
Procedure: Laparoscopic Gastrectomy
Minimally invasive surgical approach performed through traditional laparoscopy.
Patients who will be treated for gastric cancer with traditional open surgery.
- Rate of patients with intraoperative adverse events [ Time Frame: During surgery ]events other than the normal course of the surgery
- Mean of retrieved lymph nodes [ Time Frame: Within 30 days after surgery ]Count of retrieved lymph nodes at the histopathological examination of the surgical specimen
- Rate of patients alive [ Time Frame: 1 year after surgery ]subjects alive at the planned endpoint
- Rate of patients alive [ Time Frame: 2 year after surgery ]subjects alive at the planned endpoint
- Rate of patients alive [ Time Frame: 3 year after surgery ]subjects alive at the planned endpoint
- Rate of patients alive [ Time Frame: 4 year after surgery ]subjects alive at the planned endpoint
- Rate of patients alive [ Time Frame: 5 year after surgery ]subjects alive at the planned endpoint
- Mean post-operative hospital stay [ Time Frame: from the day after surgery to patient discharge, assessed up to 90 days ]hospital stay of the patients after surgery
- Rate of complications after discharge [ Time Frame: 5 year after surgery ]any surgical related event after patient's discharge
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751086
|Contact: Jacopo Desiderio, MDfirstname.lastname@example.org|
|Principal Investigator:||Amilcare Parisi, MD||St. Mary's Hospital of Terni|