Chinese Surgical Robot Clinical Study on Rectectomy for Rectal Cancer

NCT04836741 | Completed DMC

• 1 other identifier: XY3-DSRCS1507A02
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (17)

• 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

• Protective ileostomy

  It was defined as ileostomy which diverted the feces to To ensure anastomotic healing

  up to 1 month after operation

• Hospital stay (day)

  It was defined as the length of hospital stay

  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

• Retrieved lymph node

  It was defined as the number of all the lymph nodes for each patien

  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

• 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

• 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

• 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

Study Arms (2)

Micro Hand S robot-assisted surgery

EXPERIMENTAL

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

Laparoscopic surgery

ACTIVE COMPARATOR

This group is consisted of 65 cases performed using the laparoscope by one single surgeon for rectal cancer

Device: Laparoscope

Interventions

Micro Hand S robot DEVICE

The surgeries are performed with the Micro Hand S robot

Micro Hand S robot-assisted surgery

Laparoscope DEVICE

The surgeries are performed with the laparoscope

Laparoscopic surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed rectal cancer; ASA score \< 3

You may not qualify if:

• palliative resections, combined resections, distant metastasis, a previous history of abdominal/or pelvic surgery

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Related Publications (1)

• 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.

  PMID: 34098897 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Laparoscopes

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Endoscopes; Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: April 8, 2021
• Study Start: July 1, 2015
• Primary Completion: November 30, 2018
• Study Completion: December 31, 2019
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)