The UGIRA International Registry for RAMIG for Gastric Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChinese University of Hong Kong

About this trial

Minimally invasive gastrectomy (MIG) has gained in popularity, since it is feasible, safe and oncologically comparable to open gastrectomy, while morbidity and duration of hospitalization are reduced, quality of life is increased, and conversion rate is low.

However, several challenges are faced during MIG, such as impaired depth perception and limited range of motion of instrument tips. Robot-Assisted Minimally Invasive Gastrectomy (RAMIG) can potentially overcome these challenges, while providing comparable results regarding safety, technical feasibility, morbidity and oncological effectiveness. However, the techniques and outcomes of RAMIG vary in literature, which can partly be explained by lack of uniform definitions of postoperative outcomes that would allow international comparison. Furthermore, RAMIG is technically demanding and therefore associated with a learning curve.

To facilitate safe and effective implementation of RAMIG worldwide, the learning curve for RAMIG-procedures must be evaluated in detail. A prospective international registry with uniform data collection regarding surgical techniques and postoperative outcomes can provide a platform for multicontinental studies and the monitoring of surgical quality for surgeons who are implementing RAMIG in their center. Therefore, the aim of this study proposal is to expand the Upper Gastrointestinal International Robotic Association (UGIRA) collaboration by creating the UGIRA International Registry for RAMIG. The UGIRA network extends worldwide with members in Europe, Asia, North-America and South-America, therefore representing large-scale practice of RAMIG. The initial specific aims of the registry are to gain insight in surgical techniques and postoperative outcomes of RAMIG worldwide, and to evaluate the learning curve for RAMIG.

Data for this registry is collected prospectively and retrospectively.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All gastric cancer patients undergoing RAMIG in a center

Disqualifiers

No

Trial population

All gastric cancer patients undergoing RAMIG in a center

Trial design

Design model

Case-only

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: All patients undergoing Robot-Assisted Minimally Invasive Gastrectomy.

Trial outcomes

Primary outcomes

1

Operation Outcome - operating time

Operating time (minutes)

Time frame
During the entire length of the operation
2

Operation Outcome - intraoperative blood loss

intraoperative blood loss (milliliters)

Time frame
During the entire length of the operation
3

Operation Outcome - intraoperative complications

intraoperative complications (percentage)

Time frame
During the entire length of the operation
4

Operation Outcome - conversion rate

conversion rate (percentage)

Time frame
During the entire length of the operation

Secondary outcomes

1

Adverse Event and Serious Adverse Event

Any postoperative complications (e.g. anastomotic or duodenal stump leakage, pneumonia, abdominal abscess, chyle leakage, ileus, wound infection), length of stay (days) on the intensive care unit (ICU) and in the hospital, and postoperative mortality (within 30 and 90 days after surgery).

Time frame
within 30 and 90 days after surgery

Other outcomes

Sponsors and contacts

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