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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04836741
Other study ID # XY3-DSRCS1507A02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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