Rectal Cancer PatientsNCT06824688
Single-port Versus Multi-port Robotic Surgery for Rectal Cancer
A study testing Single-port robotic total mesorectal excision and Multi-port robotic total mesorectal excision in people with Rectal Cancer Patients and Robotic Surgical Procedures, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Single-port versus multi-port robotic surgery for rectal cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer Patients, Robotic Surgical Procedures
- What is being tested?
- Single-port robotic total mesorectal excision and Multi-port robotic total mesorectal excision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion criteria comprised: (1) MRI-confirmed distal tumor margin <15 cm from the anal verge, (2) biopsy-proven adenocarcinoma, (3) clinical stage I-III (AJCC 8th edition) with potential downstaging post-neoadjuvant therapy, (4) intent-to-treat with sphincter preservation and primary anastomosis, (5) documented informed consent, and (6) adult patients (≥18 years).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huichao Zheng
Chongqing
Huichao Zheng, MD, 68729350, 625730455@qq.com
About this study
Official title: Efficacy and Safety Assessment of Single-port Versus Multi-port Robotic Surgery for Rectal Cancer: a Phase 2 Non-randomized Controlled Study Based on the IDEAL Framework
Single-port versus multi-port robotic surgery for rectal cancer
Read the detailed description
This study is a stage 2 clinical trial based on the IDEAL framework, which aims to evaluate the safety and short-term clinical efficacy of single-port robotic total mesorectal excision by comparing it with multi-port robotic total mesorectal excision. The primary endpoint is short-term clinical efficacy, including intraoperative complications, blood loss, conversion rate, operation time, postoperative complications within 30 days, time to first flatus after surgery, and postoperative hospital stay. Secondary endpoints include incision length, visual analog scale (VAS) scores for postoperative pain on days 1-3, completeness of mesorectal excision grading, positive circumferential resection margin rate, positive distal resection margin rate, and the number of harvested lymph nodes.
This study was conducted in two phases:
Phase I (Stage 2a): A single-arm study of single-port robotic radical resection for rectal cancer (n=20) Phase II (Stage 2b): A prospective non-randomized controlled study comparing single-port (n=100) versus multi-port (n=100) robotic radical resection for rectal cancer
- Being tested
- Single-port robotic total mesorectal excision, Multi-port robotic total mesorectal excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-port robotic total mesorectal excisionProcedure or surgery
Single-port robotic total mesorectal excision
Multi-port robotic total mesorectal excisionProcedure or surgery
Multi-port robotic total mesorectal excision
| Study group | Role | What they receive |
|---|---|---|
| Single-port robotic total mesorectal excision | Experimental | Single-port robotic total mesorectal excision Receives: Procedure: Single-port robotic total mesorectal excision |
| Multi-port robotic total mesorectal excision | Active comparator | Multi-port robotic total mesorectal excision Receives: Procedure: Multi-port robotic total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of perioperative complications
Perioperative complications will be described using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v. 4.03 criteria. Complications will refer to any medical occurrence directly attributed to the surgical procedure during and within the first 30 days.
Measured: Intraoperative and postoperative 30 days
Number of participants with conversion procedures
The number of patients converted from robotic to open or laparoscopic surgery
Measured: Date of surgery (Day 1)
Secondary outcomes (3)
Pain scores
Visual Analog Scale (VAS) pain scores for patients on postoperative days 1-3
Measured: Postoperative days 1-3
Quality of specimen
As proposed and published by Quirke et al（Macroscopic evaluation of rectal cancer resection specimen: clinical significance of the pathologist in quality control. J Clin Oncol. 2002 Apr 1;20(7):1729-34.）
Measured: Date of surgery (Day 1)
Total length of incisions
Total length of all abdominal incisions (measured in millimeters).
Measured: Date of surgery (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start26 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer PatientsStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fan Li, Study director, Army Medical Center (Daping Hospital), Army Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824688
- Sponsor's protocol ID
- SPORTS-02
- Status last verified
- Aug 2026
- First submitted
- 25 Dec 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Assessment of Single-port Versus Multi-port Robotic Surgery for Rectal Cancer: a Phase 2 Non-randomized Controlled Study Based on the IDEAL Framework
- ClinicalTrials.gov ID
- NCT06824688
- Acronym / sponsor ID
- SPORTS-02
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 26 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Feb 2025 (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.
Single-port versus multi-port robotic surgery for rectal cancer
Detailed description
This study is a stage 2 clinical trial based on the IDEAL framework, which aims to evaluate the safety and short-term clinical efficacy of single-port robotic total mesorectal excision by comparing it with multi-port robotic total mesorectal excision. The primary endpoint is short-term clinical efficacy, including intraoperative complications, blood loss, conversion rate, operation time, postoperative complications within 30 days, time to first flatus after surgery, and postoperative hospital stay. Secondary endpoints include incision length, visual analog scale (VAS) scores for postoperative pain on days 1-3, completeness of mesorectal excision grading, positive circumferential resection margin rate, positive distal resection margin rate, and the number of harvested lymph nodes.
This study was conducted in two phases:
Phase I (Stage 2a): A single-arm study of single-port robotic radical resection for rectal cancer (n=20) Phase II (Stage 2b): A prospective non-randomized controlled study comparing single-port (n=100) versus multi-port (n=100) robotic radical resection for rectal cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-port robotic total mesorectal excision | Experimental | Procedure: Single-port robotic total mesorectal excisionSingle-port robotic total mesorectal excision |
| Multi-port robotic total mesorectal excision | Active comparator | Procedure: Multi-port robotic total mesorectal excisionMulti-port robotic total mesorectal excision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Single-port robotic total mesorectal excisionSingle-port robotic total mesorectal excision | Procedure or surgery | Single-port robotic total mesorectal excision |
| Multi-port robotic total mesorectal excisionMulti-port robotic total mesorectal excision | Procedure or surgery | Multi-port robotic total mesorectal excision |
Primary outcome
Incidence of perioperative complications
Time frame: Intraoperative and postoperative 30 days
Perioperative complications will be described using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v. 4.03 criteria. Complications will refer to any medical occurrence directly attributed to the surgical procedure during and within the first 30 days.
Number of participants with conversion procedures
Time frame: Date of surgery (Day 1)
The number of patients converted from robotic to open or laparoscopic surgery
3 secondary outcomes
Pain scores
Time frame: Postoperative days 1-3
Quality of specimen
Time frame: Date of surgery (Day 1)
Total length of incisions
Time frame: Date of surgery (Day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
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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.
Fan Li study director
Army Medical Center (Daping Hospital), Army Medical 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 Single-port robotic total mesorectal excision and Multi-port robotic total mesorectal excision in people with Rectal Cancer Patients and Robotic Surgical Procedures, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical 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?
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: looking for participants now, as of the sponsor's last update on 4 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huichao Zheng, MD (68757350, 625730455@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of perioperative complications (time frame: Intraoperative and postoperative 30 days). 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?
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 4 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.