Single-Port Colorectal SurgeriesNCT06141421
A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Colorectal Surgeries（SPiM-RWS-CR）
An observational study of Single-Port Colorectal Surgeries, run by Ruijin Hospital at 1 site in China.
Trial summary
A real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port robot-assisted colorectal surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Single-Port Colorectal Surgeries
- What is being tested?
- procedure
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2023to 15 Aug 2024
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Subjects who have received or plan to receive colorectal surgeries with the SP single-port robot, such as low anterior resection of the rectum with or without total mesorectal excision; right hemicolectomy, left hemicolectomy and sigmoidectomy with or without transanal total mesocolic excision and central blood vessel ligation; and transanal minimally invasive surgery.
Who may be able to join
- Subjects who have received or plan to receive colorectal surgeries with the SP single-port robot, such as low anterior resection of the rectum with or without total mesorectal excision; right hemicolectomy, left hemicolectomy and sigmoidectomy with or without transanal total mesocolic excision and central blood vessel ligation; and transanal minimally invasive surgery.
- Patients who voluntarily decide to participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC).
Who cannot join
- Patients with missing data on the primary endpoint in retrospective cases;
- Subjects having any contraindications of single-port robot surgery;
- The intraoperative anatomy determined that minimally invasive surgery was not suitable;
- Patients who are considered inappropriate to participate in this study by investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Colorectal Surgeries
A real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port robot-assisted colorectal surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population.
English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.
- Conditions
- Single-Port Colorectal Surgeries
- Being tested
- procedure
- Keywords
- Single-Port Colorectal Surgeries, low anterior resection of the rectum with or without total mesorectal excision, right hemicolectomy, left hemicolectomy and sigmoidectomy with or without transanal total mesocolic excision and central blood vessel ligation, transanal minimally invasive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procedureProcedure or surgery
procedure
| Study group | Role | What they receive |
|---|---|---|
| RWS study for SP CR Surgeries da Vinci SP Surgical System(SP1098) | Not described Receives: Procedure: procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative conversion rate
Measured: Intraoperative
The incidence of device-related or likely related complications of Clavien-Dindo classification grade III or higher at postoperative 30 days
Measured: 30 days
Secondary outcomes (8)
Intraoperative bleeding volume
Measured: Intraoperative
The rate of intraoperative blood transfusion
Measured: Intraoperative
Surgical duration
Measured: Intraoperative
Length of stay (LOS)
Measured: During the follow-up 1 day before discharge
Admission to ICU and ICU LOS
Measured: During the follow-up 1 day before discharge
Urethral catheter indwelling duration
Measured: in the follow-up 1 month after the surgery
Postoperative pain score
Measured: follow-ups 1 day (24±4 h), 3 days (72±4 h) and 1 month (30±5 days) after the surgery.
Short-term recovery of functions
Measured: in the follow-up 1 month after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2023
- Study start28 Mar 2023
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
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 Single-Port Colorectal SurgeriesStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Ren, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141421
- Sponsor's protocol ID
- ISFMT-SP-003
- Status last verified
- Dec 2024
- First submitted
- 15 Nov 2023
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Huang C, Shi Y, Song Z, Gong X, Jiang Y, Liu K, Zhang T, Zhao R. Single-port robotic-assisted colorectal surgery using the da Vinci SP system: a preliminary noncomparative exploratory cohort study. Int J Surg. 2026 Feb 1;112(2):3451-3456. doi: 10.1097/JS9.0000000000003915. Epub 2025 Nov 13.
PubMed 41247915
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Colorectal Surgeries
- ClinicalTrials.gov ID
- NCT06141421
- Acronym / sponsor ID
- ISFMT-SP-003
- Conditions
- Single-Port Colorectal Surgeries
- Keywords
- Single-Port Colorectal Surgeries, low anterior resection of the rectum with or without total mesorectal excision, right hemicolectomy, left hemicolectomy and sigmoidectomy with or without transanal total mesocolic excision and central blood vessel ligation, transanal minimally invasive surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 28 Mar 2023 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 21 Nov 2023 (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.
A real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port robot-assisted colorectal surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population.
English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RWS study for SP CR Surgeries da Vinci SP Surgical System(SP1098) | – | Procedure: procedure |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects who have received or plan to receive colorectal surgeries with the SP single-port robot, such as low anterior resection of the rectum with or without total mesorectal excision; right hemicolectomy, left hemicolectomy and sigmoidectomy with or without transanal total mesocolic excision and central blood vessel ligation; and transanal minimally invasive surgery.
Key inclusion criteria (2 listed)
- Subjects who have received or plan to receive colorectal surgeries with the SP single-port robot, such as low anterior resection of the rectum with or without total mesorectal excision; right hemicolectomy, left hemicolectomy and sigmoidectomy with or without transanal total mesocolic excision and central blood vessel ligation; and transanal minimally invasive surgery.
- Patients who voluntarily decide to participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC).
Key exclusion criteria (4 listed)
- Patients with missing data on the primary endpoint in retrospective cases;
- Subjects having any contraindications of single-port robot surgery;
- The intraoperative anatomy determined that minimally invasive surgery was not suitable;
- Patients who are considered inappropriate to participate in this study by investigator.
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 |
|---|---|---|
| procedureprocedure | Procedure or surgery | RWS study for SP CR Surgeries da Vinci SP Surgical System(SP1098) |
Primary outcome
Intraoperative conversion rate
Time frame: Intraoperative
The incidence of device-related or likely related complications of Clavien-Dindo classification grade III or higher at postoperative 30 days
Time frame: 30 days
8 secondary outcomes
Intraoperative bleeding volume
Time frame: Intraoperative
The rate of intraoperative blood transfusion
Time frame: Intraoperative
Surgical duration
Time frame: Intraoperative
Length of stay (LOS)
Time frame: During the follow-up 1 day before discharge
Admission to ICU and ICU LOS
Time frame: During the follow-up 1 day before discharge
Urethral catheter indwelling duration
Time frame: in the follow-up 1 month after the surgery
Postoperative pain score
Time frame: follow-ups 1 day (24±4 h), 3 days (72±4 h) and 1 month (30±5 days) after the surgery.
Short-term recovery of functions
Time frame: in the follow-up 1 month after the surgery
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 12 Dec 2024.
- Derived from this study: PubMed 41247915Huang C, Shi Y, Song Z, Gong X, Jiang Y, Liu K, Zhang T, Zhao R. Single-port robotic-assisted colorectal surgery using the da Vinci SP system: a preliminary noncomparative exploratory cohort study. Int J Surg. 2026 Feb 1;112(2):3451-3456. doi: 10.1097/JS9.0000000000003915. Epub 2025 Nov 13.
- Individual participant dataSharing planned: Undecided
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?
An observational study of Single-Port Colorectal Surgeries, run by Ruijin Hospital 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 2 inclusion and 4 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 12 Dec 2024. 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?
Intraoperative conversion rate (time frame: Intraoperative). The study lists 2 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 NCT06141421, 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 12 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.