An interventional study of Micro Hand S robot and Laparoscope in Rectal Cancer, sponsored by The Third Xiangya Hospital of Central South University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by The Third Xiangya Hospital of Central South University · Not applicable, Interventional, and Treatment
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 105 is above the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →The Third Xiangya Hospital of Central South University is the lead sponsor of 95 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group is consisted of 40 cases performed using the Micro Hand S robot by one single surgeon for rectal cancer
Device: Micro Hand S robot
This group is consisted of 65 cases performed using the laparoscope by one single surgeon for rectal cancer
Device: Laparoscope
The surgeries are performed with the Micro Hand S robot
The surgeries are performed with the laparoscope
Type of surgical procedure
It was defined as what type of procedure was pferformed, for example, low anterior, abdominal perineal resection
Time frame: up to 1 week after operation
Operative time (min)
It was defined as the duration from skin incision to skin closure
Time frame: up to 1 week after operation
Conversion
Conversion was defined as any change in strategy to open surgery
Time frame: up to 1 week after operation
Bloos loss (ml)
It was defined as the amount of blood in the whole surgical time
Time frame: up to 1 week after operation
Protective ileostomy
It was defined as ileostomy which diverted the feces to To ensure anastomotic healing
Time frame: up to 1 month after operation
Hospital stay (day)
It was defined as the length of hospital stay
Time frame: up to 1 month after operation
Tumor size (cm)
It was defined as the longitudinal diameter of the tumor
Time frame: up to 1 month after operation
Retrieved lymph node
It was defined as the number of all the lymph nodes for each patien
Time frame: up to 1 month after operation
pTNM stage
It was defined as the pathological stage of the tumor according the TNM classification
Time frame: up to 1 month after operation
Length of distal ressction margin (cm)
It was defined as the distance betwen the distal resection margin and the low margin of the tumor
Time frame: up to 1 month after operation
Status of the surgical margin
It was defined as whether the distal and circumferential resection margins was involved the tumor cell under microscope
Time frame: up to 1 month after operation
Quality of specimen
The quality of the speciman was graded according to the protocol proposed by Quirke
Time frame: up to 1 month after operation
Postoperative complication
It was defined as the adverse events after operation and the complications were classfied according to the Clavien-Dindo (C-D) classification
Time frame: up to 1 month after operation
International Prostate Symptom Score
It assessed the urination with 7 items
Time frame: at least12 months after operation
International Index of Erectile Function
It assessed erectile function with 5 items
Time frame: at least 12 months after operation
Local recurrence
It was defined as the tumor was again found in the pelvic cavity
Time frame: at least 1 years after operation
Disease free survival
It was defined as the duration between the operation and date of the tumor recurrence
Time frame: at least 1 years after operation
Plan to share: No
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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The Third Xiangya Hospital of Central South University