Chinese Surgical Robot Clinical Study on Rectectomy for Rectal Cancer

• ClinicalTrials.gov Identifier: NCT04836741
• Recruitment Status: Completed
• First Posted: April 8, 2021
• Last Update Posted: April 8, 2021
• Sponsor: The Third Xiangya Hospital of Central South University
• Information provided by (Responsible Party): The Third Xiangya Hospital of Central South University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Rectal Cancer	Device: Micro Hand S robot; Device: Laparoscope	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 105 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparision of the Outcomes and Learning Curve of Rectectomy for Rectal Cancer Using Diverse Minimally Technologies: Surgical Robot "Micro Hand S", Laparoscope
• Actual Study Start Date: July 1, 2015
• Actual Primary Completion Date: November 30, 2018
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Type of surgical procedure [ Time Frame: up to 1 week after operation ]
   It was defined as what type of procedure was pferformed, for example, low anterior, abdominal perineal resection
2. Operative time (min) [ Time Frame: up to 1 week after operation ]
   It was defined as the duration from skin incision to skin closure
3. Conversion [ Time Frame: up to 1 week after operation ]
   Conversion was defined as any change in strategy to open surgery
4. Bloos loss (ml) [ Time Frame: up to 1 week after operation ]
   It was defined as the amount of blood in the whole surgical time
5. Protective ileostomy [ Time Frame: up to 1 month after operation ]
   It was defined as ileostomy which diverted the feces to To ensure anastomotic healing
6. Hospital stay (day) [ Time Frame: up to 1 month after operation ]
   It was defined as the length of hospital stay
7. Tumor size (cm) [ Time Frame: up to 1 month after operation ]
   It was defined as the longitudinal diameter of the tumor
8. Retrieved lymph node [ Time Frame: up to 1 month after operation ]
   It was defined as the number of all the lymph nodes for each patien
9. pTNM stage [ Time Frame: up to 1 month after operation ]
   It was defined as the pathological stage of the tumor according the TNM classification
10. Length of distal ressction margin (cm) [ Time Frame: up to 1 month after operation ]
    It was defined as the distance betwen the distal resection margin and the low margin of the tumor
11. Status of the surgical margin [ Time Frame: up to 1 month after operation ]
    It was defined as whether the distal and circumferential resection margins was involved the tumor cell under microscope
12. Quality of specimen [ Time Frame: up to 1 month after operation ]
    The quality of the speciman was graded according to the protocol proposed by Quirke
13. Postoperative complication [ Time Frame: 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
14. International Prostate Symptom Score [ Time Frame: at least12 months after operation ]
    It assessed the urination with 7 items
15. International Index of Erectile Function [ Time Frame: at least 12 months after operation ]
    It assessed erectile function with 5 items
16. Local recurrence [ Time Frame: at least 1 years after operation ]
    It was defined as the tumor was again found in the pelvic cavity
17. Disease free survival [ Time Frame: at least 1 years after operation ]
    It was defined as the duration between the operation and date of the tumor recurrence

Eligibility Criteria

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

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

Contacts and Locations

Locations

China, Hunan

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China, 410013

Sponsors and Collaborators

The Third Xiangya Hospital of Central South University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: The Third Xiangya Hospital of Central South University
• ClinicalTrials.gov Identifier: NCT04836741
• Other Study ID Numbers: XY3-DSRCS1507A02
• First Posted: April 8, 2021
• Last Update Posted: April 8, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases