An observational study in Surgery and Gastric Cancer, sponsored by Hutom Corp. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-09-09.
Sponsored by Hutom Corp · Observational
By uploading pre-operative patient information and patient CT data to RUS™, a virtual surgical environment with patient-specific relief prediction models can be provided. First, after uploading the CT and clinical information of a gastric cancer patient diagnosed with gastric cancer through an actual endoscopic biopsy and scheduled for robotic total gastrectomy, RUS™ will operate normally to check whether patient-specific surgical navigation is available before or during surgery. In particular, when using the patient-specific surgery simulation system provided by RUS™, the CT information provides a patient-specific 3D environment well, so it will be checked regarding whether the surgeon can use it before or during surgery without any particular problems. Using RUS™ software, navigation information is used before or during surgery, and among these, parts that can be quantitatively compared with actual measurements will be evaluated as a secondary research goal. After the surgery, the investigators plan to check the amount of bleeding, duration of hospitalization, and the rate of complications by performing robot gastrointestinal resection using the navigation system to ensure that there are no problems with patient safety.
Obtain consent from a patient who is diagnosed with gastric cancer and is scheduled for robotic surgery.
Take an abdominal CT before gastric cancer surgery according to the prescribed protocol.
Upload patient information and CT information before surgery to RUS™, an endoscopic treatment image planning software, to build a 3D modeling navigation system for a patient-customized surgical environment. (Measure the time (in days) from the time the CT is uploaded to the time when the RUS™ software can be operated.)
Before surgery, use the RUS™ navigation system to check the patient's relief and anatomical structure, mark the planned trocar insertion site, and obtain distance information from the umbilical trocar.
⑤ After general anesthesia on the day of surgery, mark the Landmark 25 area on the abdominal wall using a surgical marking pen. In addition, the abdominal wall surface scan is performed using a laser 3D scanner.
⑥ After the undulations are formed, the deformed abdominal wall surface is scanned with a laser 3D scanner.
⑦ Evaluate the degree of agreement between the patient's actual relief state measured in steps ⑤ and ⑥ and the patient's relief model predicted through the relief prediction model in RUS™.
⑧ When the trocar is inserted through an anatomical landmark after the actual patient's relief, compare the position information of the trocar with the trocar position information of the RUS™ measured in advance in step ④ to check its accuracy.
⑨ Check whether the blood vessels that must be checked during the total gastrectomy procedure (left omentary artery, left umbilical vein, superior omentum, superior vena cava, left gastric artery, superior artery, and left hepatic branching left hepatic artery) are presented in the RUS™ blood vessel segmentation model.
⑩ Among the vessels mentioned in step ⑨, for the vessels suggested by RUS™ for vessels (left gastric artery, superior artery, left gastric vein, and gastric colonic vein), check the anatomical positional relationship and measure branch points during actual surgery. Check the accuracy of matching with the anatomical location information and branching distance of the segmentation model.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's planned enrollment of 36 is below the median of 274 across 670 observational studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Hutom Corp is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Diagnosed as gastric cancer Patients who will be carried out Robotic Gastrectomy in Yonsei University Health System, Severance Hospital
Among the subjects, the subjects are selected according to the following criteria:
Before participating in the clinical trial, an interview was conducted in an independent space, the purpose and contents of the clinical trial were fully explained, and the consent to participate in this study was voluntarily given (approved by the institutional research ethics review committee) and those who signed.
For reference, internal employees and immediate family members can also participate in this study unless there is a special reason for exclusion.
Exclusion Criteria:
If any of the following exclusion criteria are met among the subjects, participants will be excluded from this clinical trial:
single-arm study : prospective observational 1-arm (RUS group)
Device: RUS(TM) software : surgical navigation
This clinical trial is a sponsor-led clinical trial, and it is intended to confirm that RUS™, a surgical navigation system certified for level 2 endoscopic imaging treatment planning software, can be applied to real people as a clinical study by using preoperative CT and to confirm the safety of surgery. In addition, the secondary research objective was to examine the accuracy of the intra-abdominal surgical navigation system provided by RUS™ including: 1) the accuracy of the undulation prediction model, 2) the accuracy of the trocar insertion position, 3) the adequacy of 3D reconstruction of the main vessels, 4) the accuracy of the major vessel branching distances, 5) the intraoperative bleeding volume and operating time, and 6) the postoperative hospitalization period and complication rate were compared with the past control group.
CT turn around
After the subject's CT is uploaded to the RUS™ software and segmentation is started, it is evaluated whether the relief model is created, segmentation of organs and blood vessels, and 3D reconstruction are performed and uploaded within 3 days.
Time frame: 1 week
Patient-specific pneumoperitoneum model accuracy
The accuracy is evaluated by comparing the patient-specific relief prediction model presented by the RUS™ surgical navigation with the actual patient's relief model scan data.
Time frame: 1 month
Pre-trocar insertion function accuracy
When the virtual trocar is inserted into the relief model in RUS™, the position and distance information of the trocar is provided, and the accuracy is evaluated by comparing it with the insertion position of the real trocar.
Time frame: 1 week
Major blood vessel presentation
Evaluate whether the major blood vessels (a total of 7 (LGEA, RGEA, LGA, RGA, LGEV, RGEV, LGV)) that must be checked in total gastrectomy are 100% 3D reconstructed on the RUS™ navigation system.
Time frame: 1 week
Distance of major blood vessels
By comparing the branching distance of major blood vessels in RUS™ (total 7 (LGEA, RGEA, LGA, RGA, LGEV, RGEV, LGV)) and the branching distance of major blood vessels during actual surgery, it is evaluated whether the accuracy is greater than 90%.
Time frame: 1 week
Bleeding volume
When robotic total gastrectomy is performed using RUS™ surgical navigation, the amount of bleeding is measured and compared with the previous control group.
Time frame: 1 day
Surgery time
When robotic total gastric resection is performed using RUS™ surgical navigation, the operation time (console time in the case of robotic surgery) is measured and compared with the past control group.
Time frame: 1 day
Hospital stay after surgery
When robotic total gastrectomy is performed using RUS™ surgical navigation, the patient's postoperative hospital stay is checked and compared with the past control group.
Time frame: 1 month
Complication rate
When robotic total gastric resection is performed using RUS™ surgical navigation, the patient's complication rate is checked and compared with the past control group.
Time frame: 1 month
Plan to share: No
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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