Rectal Cancer
Conditions
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.
Interventions
DEVICEMicro Hand S robot and da Vinci robot
The surgeries are performed with the Micro Hand S robot and da Vinci robot
DEVICEda Vinci robot
The surgeries are performed with the da Vinci robot
Sponsors
The Third Xiangya Hospital of Central South University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| learning curve of console time | up to 1 week after operation | It was defined the cumulative sum plot of the consloe time in the chronological order. |
| learning curve of docking time | up to 1 week after operation | It was defined the cumulative sum plot of the docking time in the chronological order. |
| learning curve of surgicla failure | up to 1 week after operation | It was defined the cumulative sum plot of the docking time in the chronological order. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Docking time (min) | up to 1 week after operation | The docking time was the time from moving robotic instruments in the surgical field to setting robotic arms into the port sites |
| Conversion | up to 1 week after operation | Conversion was defined as any change in strategy to open surgery |
| Bloos loss (ml) | up to 1 week after operation | It was defined as the amount of blood in the whole surgical time |
| Hospital stay (day) | up to 1 month after operation | It was defined as the length of hospital stay |
| Protective ileostomy | up to 1 month after operation | It was defined as ileostomy which diverted the feces to to ensure anastomotic healing |
| Retrieved lymph node | up to 1 month after operation | It was defined as the number of all the lymph nodes for each patient |
| Surgical failure | up to 1 month after operation | Surgical failure was defined as the presence of one or more of the following four parameters: conversion, the positive surgical margins, severe postoperative complications, the number of harvested lymph nodes less than 12 |
| Type of surgical procedure | up to 1 week after operation | It was defined as what type of procedure was pferformed, for example, low anterior, abdominal perineal resection |
| Tumor size (cm) | up to 1 month after operation | It was defined as the longitudinal diameter of the tumor |
| Length of distal ressction margin (cm) | up to 1 month after operation | It was defined as the distance betwen the distal resection margin and the low margin of the tumor |
| Status of the surgical margin | up to 1 month after operation | It was defined as whether the distal and circumferential resection margins was involved the tumor cell under microscope |
| Quality of specimen | up to 1 month after operation | The quality of the speciman was graded according to the protocol proposed by Quirke |
| Postoperative complication | up to 1 month after operation | It was defined as the adverse events after operation and the complications were classfied according to the Clavien-Dindo (C-D) classification |
| Local recurrence | at least 1 years after operation | It was defined as the tumor was again found in the pelvic cavity |
| Disease free survival | at least 1 years after operation | It was defined as the duration between the operation and date of the tumor recurrence |
| pTNM stage | up to 1 month after operation | It was defined as the pathological stage of the tumor according the TNM classification |
| Operative time (min) | up to 1 week after operation | It was defined as the duration from skin incision to skin closure |
| Console time (min) | up to 1 week after operation | The console time was defined the fime that the surgeon performed the surgeon console. |
Countries
China
Outcome results
None listed