Chinese Surgical Robot Clinical Study on Rectectomy for Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04836741
• Other study ID #: XY3-DSRCS1507A02
• Status: Completed
• Phase: N/A
• Start date: July 1, 2015
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2021
• Source: The Third Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Device:
• Micro Hand S robot
The surgeries are performed with the Micro Hand S robot
• Laparoscope
The surgeries are performed with the laparoscope

Locations

Country	Name	City	State
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

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