Rectal CancerNCT04855448
Evaluation of the Learning Curve in Low Anterior Resection for Rectal Resection With the Two Surgical Robots
A study testing Micro Hand S robot and da Vinci robot and da Vinci robot in people with Rectal Cancer, run by The Third Xiangya Hospital of Central South University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Micro Hand S robot and da Vinci robot and da Vinci robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed rectal cancer; ASA score ≤ 3
Who cannot join
- palliative resections, combined resections, distant metastasis, a previous history of abdominal/or pelvic surgery
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
Official title: Accelerated Learning Curve in Low Anterior Resection for Rectal Resection, a New Surgical Robot Micro Hand S Versus da Vinci, Can be Attained Simultaneously: a Single Center Experience
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, the learning curve in low anterior resection for rectal resection with the Micro Hand S robot are unclear and whether the two surgical robots (Micro Hand S and da Vinci) shared a similar learning curve and the two robot can be trained simultaneously. Therefore, the investigators conduct this retrospective study to focus on this concern.
Read the detailed description
The Micro Hand S robor has been appiled in low anterior resection for rectal cancer. The safey and feasibility has been evaluated. However, the learning curve of this procedure is unclear. Specially,whether the two surgical robots (Micro Hand S and da Vinci) shared a similar learning curve and the two robot can be trained simultaneously are unclear.Therefore, this srudy is conducted to evaluate the learning curve of the two robots in low anterior resection.
- Conditions
- Rectal Cancer
- Being tested
- Micro Hand S robot and da Vinci robot, da Vinci robot
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro Hand S robot and da Vinci robotDevice
The surgeries are performed with the Micro Hand S robot and da Vinci robot
da Vinci robotDevice
The surgeries are performed with the da Vinci robot
| Study group | Role | What they receive |
|---|---|---|
| Surgeon A | Experimental | This group is consisted of 56 cases performed using the Micro Hand S robot and da Vinci robot by one single surgeon in low anterior resection for rectal cancer Receives: Device: Micro Hand S robot and da Vinci robot |
| Surgeon B | Active comparator | This group is consisted of 56 cases performed using the da Vinci robot by one single surgeon in low anterior resection for rectal cancer Receives: Device: da Vinci robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
learning curve of console time
It was defined the cumulative sum plot of the consloe time in the chronological order.
Measured: up to 1 week after operation
learning curve of docking time
It was defined the cumulative sum plot of the docking time in the chronological order.
Measured: up to 1 week after operation
learning curve of surgicla failure
It was defined the cumulative sum plot of the docking time in the chronological order.
Measured: up to 1 week after operation
Secondary outcomes (18)
Type of surgical procedure
It was defined as what type of procedure was pferformed, for example, low anterior, abdominal perineal resection
Measured: up to 1 week after operation
Operative time (min)
It was defined as the duration from skin incision to skin closure
Measured: up to 1 week after operation
Console time (min)
The console time was defined the fime that the surgeon performed the surgeon console.
Measured: up to 1 week after operation
Docking time (min)
The docking time was the time from moving robotic instruments in the surgical field to setting robotic arms into the port sites
Measured: up to 1 week after operation
Conversion
Conversion was defined as any change in strategy to open surgery
Measured: up to 1 week after operation
Bloos loss (ml)
It was defined as the amount of blood in the whole surgical time
Measured: up to 1 week after operation
Hospital stay (day)
It was defined as the length of hospital stay
Measured: up to 1 month after operation
Protective ileostomy
It was defined as ileostomy which diverted the feces to to ensure anastomotic healing
Measured: up to 1 month after operation
Retrieved lymph node
It was defined as the number of all the lymph nodes for each patient
Measured: up to 1 month after operation
Surgical failure
Surgical failure was defined as the presence of one or more of the following four parameters: conversion, the positive surgical margins, severe postoperative complications, the number of harvested lymph nodes less than 12
Measured: up to 1 month after operation
pTNM stage
It was defined as the pathological stage of the tumor according the TNM classification
Measured: up to 1 month after operation
Tumor size (cm)
It was defined as the longitudinal diameter of the tumor
Measured: 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
Measured: 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
Measured: up to 1 month after operation
Quality of specimen
The quality of the speciman was graded according to the protocol proposed by Quirke
Measured: 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
Measured: up to 1 month after operation
Local recurrence
It was defined as the tumor was again found in the pelvic cavity
Measured: at least 1 years after operation
Disease free survival
It was defined as the duration between the operation and date of the tumor recurrence
Measured: at least 1 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 May 2017
- Primary completion31 Aug 2018
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855448
- Sponsor's protocol ID
- XY3-DSRCS1507A04
- Status last verified
- Apr 2021
- First submitted
- 18 Apr 2021
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Learning Curve in Low Anterior Resection for Rectal Resection, a New Surgical Robot Micro Hand S Versus da Vinci, Can be Attained Simultaneously: a Single Center Experience
- ClinicalTrials.gov ID
- NCT04855448
- Acronym / sponsor ID
- XY3-DSRCS1507A04
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, the learning curve in low anterior resection for rectal resection with the Micro Hand S robot are unclear and whether the two surgical robots (Micro Hand S and da Vinci) shared a similar learning curve and the two robot can be trained simultaneously. Therefore, the investigators conduct this retrospective study to focus on this concern.
Detailed description
The Micro Hand S robor has been appiled in low anterior resection for rectal cancer. The safey and feasibility has been evaluated. However, the learning curve of this procedure is unclear. Specially,whether the two surgical robots (Micro Hand S and da Vinci) shared a similar learning curve and the two robot can be trained simultaneously are unclear.Therefore, this srudy is conducted to evaluate the learning curve of the two robots in low anterior resection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgeon A | Experimental | Device: Micro Hand S robot and da Vinci robotThis group is consisted of 56 cases performed using the Micro Hand S robot and da Vinci robot by one single surgeon in low anterior resection for rectal cancer |
| Surgeon B | Active comparator | Device: da Vinci robotThis group is consisted of 56 cases performed using the da Vinci robot by one single surgeon in low anterior resection for rectal cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- histologically confirmed rectal cancer; ASA score ≤ 3
Key exclusion criteria (1 listed)
- palliative resections, combined resections, distant metastasis, a previous history of abdominal/or pelvic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro Hand S robot and da Vinci robotThe surgeries are performed with the Micro Hand S robot and da Vinci robot | Device | Surgeon A |
| da Vinci robotThe surgeries are performed with the da Vinci robot | Device | Surgeon B |
Primary outcome
learning curve of console time
Time frame: up to 1 week after operation
It was defined the cumulative sum plot of the consloe time in the chronological order.
learning curve of docking time
Time frame: up to 1 week after operation
It was defined the cumulative sum plot of the docking time in the chronological order.
learning curve of surgicla failure
Time frame: up to 1 week after operation
It was defined the cumulative sum plot of the docking time in the chronological order.
18 secondary outcomes
Type of surgical procedure
Time frame: up to 1 week after operation
Operative time (min)
Time frame: up to 1 week after operation
Console time (min)
Time frame: up to 1 week after operation
Docking time (min)
Time frame: up to 1 week after operation
Conversion
Time frame: up to 1 week after operation
Bloos loss (ml)
Time frame: up to 1 week after operation
Hospital stay (day)
Time frame: up to 1 month after operation
Protective ileostomy
Time frame: up to 1 month after operation
Retrieved lymph node
Time frame: up to 1 month after operation
Surgical failure
Time frame: up to 1 month after operation
pTNM stage
Time frame: up to 1 month after operation
Tumor size (cm)
Time frame: up to 1 month after operation
Length of distal ressction margin (cm)
Time frame: up to 1 month after operation
Status of the surgical margin
Time frame: up to 1 month after operation
Quality of specimen
Time frame: up to 1 month after operation
Postoperative complication
Time frame: up to 1 month after operation
Local recurrence
Time frame: at least 1 years after operation
Disease free survival
Time frame: at least 1 years after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro Hand S robot and da Vinci robot and da Vinci robot in people with Rectal Cancer, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
learning curve of console time (time frame: up to 1 week after operation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.