Clinical trial NCT04855448: Evaluation of the Learning Curve in Low Anterior Resection for Rectal Resection With the Two Surgical Robots
Official title: Accelerated Learning Curve in Low Anterior Resection for Rectal Resection, a New Surgical Robot Micro Hand S Versus da Vinci, Can be Attained Simultaneously: a Single Center Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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. 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. The Micro Hand S robot is safe and feasible in the preliminary study. However, the learning curve in low anterior resection for rectal resection with the Micro Hand S robot are unclear and whether the two surgical robots (Micro Hand S and da Vinci) shared a similar learning curve and the two robot can be trained simultaneously. Therefore, the investigators conduct this retrospective study to focus on this concern.

Detailed description: The Micro Hand S robor has been appiled in low anterior resection for rectal cancer. The safey and feasibility has been evaluated. However, the learning curve of this procedure is unclear. Specially,whether the two surgical robots (Micro Hand S and da Vinci) shared a similar learning curve and the two robot can be trained simultaneously are unclear.Therefore, this srudy is conducted to evaluate the learning curve of the two robots in low anterior resection.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed rectal cancer; ASA score ≤ 3

Exclusion Criteria:

* palliative resections, combined resections, distant metastasis, a previous history of abdominal/or pelvic surgery

Primary outcomes:
measure: learning curve of console time
timeFrame: up to 1 week after operation
measure: learning curve of docking time
timeFrame: up to 1 week after operation
measure: learning curve of surgicla failure
timeFrame: up to 1 week after operation
Secondary outcomes:
measure: Type of surgical procedure
timeFrame: up to 1 week after operation
measure: Operative time (min)
timeFrame: up to 1 week after operation
measure: Console time (min)
timeFrame: up to 1 week after operation
measure: Docking time (min)
timeFrame: up to 1 week after operation
measure: Conversion
timeFrame: up to 1 week after operation
measure: Bloos loss (ml)
timeFrame: up to 1 week after operation
measure: Hospital stay (day)
timeFrame: up to 1 month after operation
measure: Protective ileostomy
timeFrame: up to 1 month after operation
measure: Retrieved lymph node
timeFrame: up to 1 month after operation
measure: Surgical failure
timeFrame: up to 1 month after operation
measure: pTNM stage
timeFrame: up to 1 month after operation
measure: Tumor size (cm)
timeFrame: up to 1 month after operation
measure: Length of distal ressction margin (cm)
timeFrame: up to 1 month after operation
measure: Status of the surgical margin
timeFrame: up to 1 month after operation
measure: Quality of specimen
timeFrame: up to 1 month after operation
measure: Postoperative complication
timeFrame: up to 1 month after operation
measure: Local recurrence
timeFrame: at least 1 years after operation
measure: Disease free survival
timeFrame: at least 1 years after operation
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: