Rectal CancerNCT04836741
Chinese Surgical Robot Clinical Study on Rectectomy for Rectal Cancer
A study testing Micro Hand S robot and Laparoscope 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 Laparoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2015to 31 Dec 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: Comparision of the Outcomes and Learning Curve of Rectectomy for Rectal Cancer Using Diverse Minimally Technologies: Surgical Robot "Micro Hand S", Laparoscope
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
- Being tested
- Micro Hand S robot, Laparoscope
- 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 robotDevice
The surgeries are performed with the Micro Hand S robot
LaparoscopeDevice
The surgeries are performed with the laparoscope
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Laparoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Protective ileostomy
It was defined as ileostomy which diverted the feces to To ensure anastomotic healing
Measured: up to 1 month after operation
Hospital stay (day)
It was defined as the length of hospital stay
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
Retrieved lymph node
It was defined as the number of all the lymph nodes for each patien
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
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
International Prostate Symptom Score
It assessed the urination with 7 items
Measured: at least12 months after operation
International Index of Erectile Function
It assessed erectile function with 5 items
Measured: at least 12 months 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 posted8 Apr 2021
- Study start1 Jul 2015
- Primary completion30 Nov 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 105 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04836741
- Sponsor's protocol ID
- XY3-DSRCS1507A02
- Status last verified
- Apr 2021
- First submitted
- 29 Mar 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34098897
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparision of the Outcomes and Learning Curve of Rectectomy for Rectal Cancer Using Diverse Minimally Technologies: Surgical Robot "Micro Hand S", Laparoscope
- ClinicalTrials.gov ID
- NCT04836741
- Acronym / sponsor ID
- XY3-DSRCS1507A02
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 8 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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micro Hand S robot-assisted surgery | Experimental | Device: Micro Hand S robotThis group is consisted of 40 cases performed using the Micro Hand S robot by one single surgeon for rectal cancer |
| Laparoscopic surgery | Active comparator | Device: LaparoscopeThis group is consisted of 65 cases performed using the laparoscope by one single surgeon 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 robotThe surgeries are performed with the Micro Hand S robot | Device | Micro Hand S robot-assisted surgery |
| LaparoscopeThe surgeries are performed with the laparoscope | Device | Laparoscopic surgery |
Primary outcome
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
Operative time (min)
Time frame: up to 1 week after operation
It was defined as the duration from skin incision to skin closure
Conversion
Time frame: up to 1 week after operation
Conversion was defined as any change in strategy to open surgery
Bloos loss (ml)
Time frame: up to 1 week after operation
It was defined as the amount of blood in the whole surgical time
Protective ileostomy
Time frame: up to 1 month after operation
It was defined as ileostomy which diverted the feces to To ensure anastomotic healing
Hospital stay (day)
Time frame: up to 1 month after operation
It was defined as the length of hospital stay
Tumor size (cm)
Time frame: up to 1 month after operation
It was defined as the longitudinal diameter of the tumor
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
pTNM stage
Time frame: up to 1 month after operation
It was defined as the pathological stage of the tumor according the TNM classification
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
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
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
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
International Prostate Symptom Score
Time frame: at least12 months after operation
It assessed the urination with 7 items
International Index of Erectile Function
Time frame: at least 12 months after operation
It assessed erectile function with 5 items
Local recurrence
Time frame: at least 1 years after operation
It was defined as the tumor was again found in the pelvic cavity
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
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 8 Apr 2021.
- Derived from this study: PubMed 34098897Wang 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.
- Individual participant dataSharing planned: No
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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 Laparoscope 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 8 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?
Type of surgical procedure (time frame: up to 1 week after operation). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04836741, which also lists 1 linked publication.
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 8 Apr 2021.