Clinical trial NCT04836741: Chinese Surgical Robot Clinical Study on Rectectomy for Rectal Cancer
Official title: Comparision of the Outcomes and Learning Curve of Rectectomy for Rectal Cancer Using Diverse Minimally Technologies: Surgical Robot "Micro Hand S", Laparoscope
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: 2021-04-08
Enrollment: 105
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, 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.


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: Type of surgical procedure
timeFrame: up to 1 week after operation
measure: Operative 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: Protective ileostomy
timeFrame: up to 1 month after operation
measure: Hospital stay (day)
timeFrame: up to 1 month after operation
measure: Tumor size (cm)
timeFrame: up to 1 month after operation
measure: Retrieved lymph node
timeFrame: up to 1 month after operation
measure: pTNM stage
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: International Prostate Symptom Score
timeFrame: at least12 months after operation
measure: International Index of Erectile Function
timeFrame: at least 12 months after operation
measure: Local recurrence
timeFrame: at least 1 years after operation
measure: Disease free survival
timeFrame: at least 1 years after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
citation: Wang Y, Wang G, Li Z, Ling H, Yi B, Zhu S. Comparison of the operative outcomes and learning curves between laparoscopic and "Micro Hand S" robot-assisted total mesorectal excision for rectal cancer: a retrospective study. BMC Gastroenterol. 2021 Jun 7;21(1):251. doi: 10.1186/s12876-021-01834-1.