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| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000006910 | Other Identifier | UMIN |
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The aim of this study is to clarify safety of robot assisted distal gastrectomy with lymph node dissection in patients with stage Ia early gastric cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot assisted distal gastrectomy | Experimental | patients who received robot assisted distal gastrectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot assisted distal gastrectomy (DaVinci) | Device | patients who received robot assisted distal gastrectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Post-operative Intra-abdominal Infectious Complications | Participants will be followed for the duration of hospital stay, an expected average of 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | 5 years | |
| Relapse Free Survival | 5 years | |
| Completion Rate of Robot Assisted Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Masanori Terashima, M.D., Ph.D. | Division of Gastric Surgery, Shizuoka Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shizuoka Cancer Center | Shizuoka | 411-0934 | Japan |
A total of 23 patients were recruited for the study, and the initial 5 cases were excluded from the primary analysis because some of the initial RAGs were performed by invited surgeons who had lots of experience. This exclusion was prespecified in the protocol. Therefore, only the remaining 18 patients were included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Robot Assisted Distal Gastrectomy | patients who received robot assisted distal gastrectomy Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Robot Assisted Distal Gastrectomy | patients who received robot assisted distal gastrectomy Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Incidence of Post-operative Intra-abdominal Infectious Complications | Posted | Number | 90% Confidence Interval | participants | Participants will be followed for the duration of hospital stay, an expected average of 10 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Robot Assisted Distal Gastrectomy | patients who received robot assisted distal gastrectomy Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doctor Masanori Tokunaga | Shizuoka Cancer Center | 81-55098908777 | m.tokunaga@scchr.jp |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| During the surgery, an expected average of 5 hours |
| Incidence of Adverse Events | Participants will be followed for the duration of hospital stay, an expected average of 10 days |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Overall Survival | Not Posted | 5 years |
| Secondary | Relapse Free Survival | Not Posted | 5 years |
| Secondary | Completion Rate of Robot Assisted Surgery | Not Posted | During the surgery, an expected average of 5 hours |
| Secondary | Incidence of Adverse Events | Not Posted | Participants will be followed for the duration of hospital stay, an expected average of 10 days |
| 0 |
| 18 |
| 0 |
| 18 |
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| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |