Gastric Cancer Clinical Trial
Official title:
Safety and Feasible Study of Domestic Surgical Robot That Had Been Authorized to Enter the Clinical Trial Stage
Verified date | March 2021 |
Source | The Third Xiangya Hospital of Central South University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Central South University in collaboration with Tianjin University developed the first domestically produced Chinese minimally invasive surgical (MIS) robot system which named "Micro Hand S" in 2013. Recently, as the domestic surgical robot research project's main section, this new MIS robot had been authorized to enter the clinical trial stage by the Ethics Committee of the Third Xiangya Hospital at Central South University.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | December 30, 2021 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - diagnosis of gastric tumor, colorectal tumor, acute cholecystitis and ileocecal tumor respectively - 18years<age<65years - male or female Exclusion Criteria: - patients with a history of open abdominal surgery - unstable psychiatric illness - an inability or reluctance to cooperate during long-term follow-up - alcohol or drug addiction - or relatively high surgical risks, such as abnormal coagulation function or bad heart, lung, liver and kidney function, were excluded from this study |
Country | Name | City | State |
---|---|---|---|
China | The Third Xiangya Hospital of Central South University | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
The Third Xiangya Hospital of Central South University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | intraoperative outcomes | surgical procedure/operative time/console time/blood loss/conversion | up to 1 week after operation | |
Primary | postoperative outcomes | Time to first flatus/intake/hospital stay | up to 1 month after operation | |
Primary | pathological outcomes | resection margin/harvested lymph node/mesorectal grade | up to 1 month after operation | |
Primary | complication | type of complication/grade of complication | within 30 days after surgery | |
Secondary | functional outcomes | wexner/ipss/iief score | at least12 months after operation | |
Secondary | recurrence | local recurrence and metastasis | at least 12 months after operation | |
Secondary | survival | disease free survival/overall survival | at least 12 months yesra after operation | |
Secondary | change of blood and biochemiacl | wbc/hgb/albumin/cea | within 1 month after operation |
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