Chinese Surgical Robot Clinical Study on Rectectomy for Rectal Cancer

Comparision of the Outcomes and Learning Curve of Rectectomy for Rectal Cancer Using Diverse Minimally Technologies: Surgical Robot "Micro Hand S", Laparoscope

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.

Study Overview

• Status: Completed
• Conditions: Rectal Cancer
• Intervention / Treatment: Device: Micro Hand S robot; Device: Laparoscope

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Micro Hand S robot-assisted surgery; 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; The surgeries are performed with the Micro Hand S robot
Active Comparator: Laparoscopic surgery; 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 laparoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of surgical procedure	It was defined as what type of procedure was pferformed, for example, low anterior, abdominal perineal resection	up to 1 week after operation
Operative time (min)	It was defined as the duration from skin incision to skin closure	up to 1 week after operation
Conversion	Conversion was defined as any change in strategy to open surgery	up to 1 week after operation
Bloos loss (ml)	It was defined as the amount of blood in the whole surgical time	up to 1 week after operation
Hospital stay (day)	It was defined as the length of hospital stay	up to 1 month after operation
pTNM stage	It was defined as the pathological stage of the tumor according the TNM classification	up to 1 month after operation
Tumor size (cm)	It was defined as the longitudinal diameter of the tumor	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	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	up to 1 month after operation
Quality of specimen	The quality of the speciman was graded according to the protocol proposed by Quirke	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	up to 1 month after operation
Local recurrence	It was defined as the tumor was again found in the pelvic cavity	at least 1 years after operation
Disease free survival	It was defined as the duration between the operation and date of the tumor recurrence	at least 1 years after operation
Protective ileostomy	It was defined as ileostomy which diverted the feces to To ensure anastomotic healing	up to 1 month after operation
Retrieved lymph node	It was defined as the number of all the lymph nodes for each patien	up to 1 month after operation
International Prostate Symptom Score	It assessed the urination with 7 items	at least12 months after operation
International Index of Erectile Function	It assessed erectile function with 5 items	at least 12 months after operation

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: April 5, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 5, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: XY3-DSRCS1507A02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No