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, compared with minimally invasive approaches (da Vici, laparoscope), the merits and demrits of rectectomy for rectal cancer are unclear. Therefore, the investigators conduct this retrospective study to focus on this concern.
Interventions
DEVICEMicro Hand S robot
The surgeries are performed with the Micro Hand S robot
DEVICELaparoscope
The surgeries are performed with the laparoscope
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 |
|---|---|---|
| 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 |
| Operative time (min) | up to 1 week after operation | It was defined as the duration from skin incision to skin closure |
| 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 |
| Protective ileostomy | up to 1 month after operation | It was defined as ileostomy which diverted the feces to To ensure anastomotic healing |
| Hospital stay (day) | up to 1 month after operation | It was defined as the length of hospital stay |
| Tumor size (cm) | up to 1 month after operation | It was defined as the longitudinal diameter of the tumor |
| Retrieved lymph node | up to 1 month after operation | It was defined as the number of all the lymph nodes for each patien |
| pTNM stage | up to 1 month after operation | It was defined as the pathological stage of the tumor according the TNM classification |
| 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 |
| International Prostate Symptom Score | at least12 months after operation | It assessed the urination with 7 items |
| International Index of Erectile Function | at least 12 months after operation | It assessed erectile function with 5 items |
| 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 |
Countries
China
Outcome results
None listed