Gastric Ulcer With Perforation But Without ObstructionNCT02752698
Domestic Surgical Robot Clinical Study
A study testing Micro Hand S robotic surgery, laparoscopic surgery and da Vinci robotic surgery in people with Gastric Ulcer With Perforation But Without Obstruction and Colon 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
- Gastric Ulcer With Perforation But Without Obstruction, Colon Cancer, Cholecystolithiasis
- What is being tested?
- Micro Hand S robotic surgery, laparoscopic surgery and da Vinci robotic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 30 Dec 2021
- 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
- diagnosis of gastric tumor, colorectal tumor, acute cholecystitis and ileocecal tumor respectively
- 18years<age<65years
- male or female
Who cannot join
- patients with a history of open abdominal surgery
- unstable psychiatric illness
- an inability or reluctance to cooperate during long-term follow-up
- alcohol or drug addiction
- or relatively high surgical risks, such as abnormal coagulation function or bad heart, lung, liver and kidney function, were excluded from this study
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: Safety and Feasible Study of Domestic Surgical Robot That Had Been Authorized to Enter the Clinical Trial Stage
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. Recently, as the domestic surgical robot research project's main section, 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.
Read the detailed description
One surgeon perform these surgical trials using the robot "Micro Hand S". All of the patients were followed for 12 months, and pre- and postoperative changes in blood route test and hepatorenal function examination, surgery duration, hospital stay, total robotic setup time, total robotic operation time, intraoperative blood loss, total postoperative drainage amount, duration of bearing drainage tubes were recorded. In addition, the pre- and postoperative changes in the pathological and functional outcomes were measured.
- Conditions
- Gastric Ulcer With Perforation But Without Obstruction, Colon Cancer, Cholecystolithiasis, Appendicitis, Sleeve Gastrectomy, Gastric Bypass
- Being tested
- Micro Hand S robotic surgery, laparoscopic surgery, da Vinci robotic surgery
- Medical subject headings
- Colonic Neoplasms, Cholecystolithiasis, Appendicitis, Stomach Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro Hand S robotic surgeryProcedure or surgery
20-70 patients undergo Micro Hand S robotic surgeries
laparoscopic surgeryProcedure or surgery
20-70 patients undergo laparoscopic surgeries
da Vinci robotic surgeryProcedure or surgery
20-70 patients undergo da Vinci robotic surgeries
| Study group | Role | What they receive |
|---|---|---|
| Micro Hand S robotic group | Experimental | Micro Hand S robotic surgery group Receives: Procedure: Micro Hand S robotic surgery |
| laparoscopic surgery | Other | laparoscopic surgery group Receives: Procedure: laparoscopic surgery |
| da Vinci robotic group | Other | da Vinci robotic robotic group Receives: Procedure: da Vinci robotic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative outcomes
surgical procedure/operative time/console time/blood loss/conversion
Measured: up to 1 week after operation
postoperative outcomes
Time to first flatus/intake/hospital stay
Measured: up to 1 month after operation
pathological outcomes
resection margin/harvested lymph node/mesorectal grade
Measured: up to 1 month after operation
complication
type of complication/grade of complication
Measured: within 30 days after surgery
Secondary outcomes (4)
functional outcomes
wexner/ipss/iief score
Measured: at least12 months after operation
recurrence
local recurrence and metastasis
Measured: at least 12 months after operation
survival
disease free survival/overall survival
Measured: at least 12 months yesra after operation
change of blood and biochemiacl
wbc/hgb/albumin/cea
Measured: within 1 month after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study start1 Jan 2015
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric Ulcer With Perforation But Without ObstructionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- shaihong zhu, MD, Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752698
- Sponsor's protocol ID
- XY3-DSRCS1507A01
- Status last verified
- Mar 2021
- First submitted
- 15 Jun 2015
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lei Y, Jiang J, Zhu S, Yi B, Li J. Comparison of the short-term efficacy of two types of robotic total mesorectal excision for rectal cancer. Tech Coloproctol. 2022 Jan;26(1):19-28. doi: 10.1007/s10151-021-02546-0. Epub 2021 Nov 30.
PubMed 34846614Zeng Y, Wang G, Li Z, Lin H, Zhu S, Yi B. The Micro Hand S vs. da Vinci Surgical Robot-Assisted Surgery on Total Mesorectal Excision: Short-Term Outcomes Using Propensity Score Matching Analysis. Front Surg. 2021 May 11;8:656270. doi: 10.3389/fsurg.2021.656270. eCollection 2021.
PubMed 34046424
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasible Study of Domestic Surgical Robot That Had Been Authorized to Enter the Clinical Trial Stage
- ClinicalTrials.gov ID
- NCT02752698
- Acronym / sponsor ID
- XY3-DSRCS1507A01
- Conditions
- Gastric Ulcer With Perforation But Without Obstruction, Colon Cancer, Cholecystolithiasis, Appendicitis, Sleeve Gastrectomy, Gastric Bypass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 27 Apr 2016 (estimated)
- 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. Recently, as the domestic surgical robot research project's main section, 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.
Detailed description
One surgeon perform these surgical trials using the robot "Micro Hand S". All of the patients were followed for 12 months, and pre- and postoperative changes in blood route test and hepatorenal function examination, surgery duration, hospital stay, total robotic setup time, total robotic operation time, intraoperative blood loss, total postoperative drainage amount, duration of bearing drainage tubes were recorded. In addition, the pre- and postoperative changes in the pathological and functional outcomes were measured.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Micro Hand S robotic group | Experimental | Procedure: Micro Hand S robotic surgeryMicro Hand S robotic surgery group |
| laparoscopic surgery | Other | Procedure: laparoscopic surgerylaparoscopic surgery group |
| da Vinci robotic group | Other | Procedure: da Vinci robotic surgeryda Vinci robotic robotic group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of gastric tumor, colorectal tumor, acute cholecystitis and ileocecal tumor respectively
- 18years<age<65years
- male or female
Key exclusion criteria (5 listed)
- patients with a history of open abdominal surgery
- unstable psychiatric illness
- an inability or reluctance to cooperate during long-term follow-up
- alcohol or drug addiction
- or relatively high surgical risks, such as abnormal coagulation function or bad heart, lung, liver and kidney function, were excluded from this study
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 robotic surgery20-70 patients undergo Micro Hand S robotic surgeries | Procedure or surgery | Micro Hand S robotic group |
| laparoscopic surgery20-70 patients undergo laparoscopic surgeries | Procedure or surgery | laparoscopic surgery |
| da Vinci robotic surgery20-70 patients undergo da Vinci robotic surgeries | Procedure or surgery | da Vinci robotic group |
Primary outcome
intraoperative outcomes
Time frame: up to 1 week after operation
surgical procedure/operative time/console time/blood loss/conversion
postoperative outcomes
Time frame: up to 1 month after operation
Time to first flatus/intake/hospital stay
pathological outcomes
Time frame: up to 1 month after operation
resection margin/harvested lymph node/mesorectal grade
complication
Time frame: within 30 days after surgery
type of complication/grade of complication
4 secondary outcomes
functional outcomes
Time frame: at least12 months after operation
recurrence
Time frame: at least 12 months after operation
survival
Time frame: at least 12 months yesra after operation
change of blood and biochemiacl
Time frame: within 1 month after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Derived from this study: PubMed 34846614Lei Y, Jiang J, Zhu S, Yi B, Li J. Comparison of the short-term efficacy of two types of robotic total mesorectal excision for rectal cancer. Tech Coloproctol. 2022 Jan;26(1):19-28. doi: 10.1007/s10151-021-02546-0. Epub 2021 Nov 30.
- Derived from this study: PubMed 34046424Zeng Y, Wang G, Li Z, Lin H, Zhu S, Yi B. The Micro Hand S vs. da Vinci Surgical Robot-Assisted Surgery on Total Mesorectal Excision: Short-Term Outcomes Using Propensity Score Matching Analysis. Front Surg. 2021 May 11;8:656270. doi: 10.3389/fsurg.2021.656270. eCollection 2021.
- Individual participant dataSharing planned: No
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.
shaihong zhu, MD principal investigator
The Third Xiangya Hospital of Central South University
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 robotic surgery, laparoscopic surgery and da Vinci robotic surgery in people with Gastric Ulcer With Perforation But Without Obstruction and Colon 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 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?
Results are not available in the source record.
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?
intraoperative outcomes (time frame: up to 1 week after operation). The study lists 4 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 NCT02752698, which also lists 2 linked publications.
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 1 Apr 2021.