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Rectal CancerNCT06943690

Safety and Efficacy Study of Single-port Robotic Versus Multi-port Robotic Radical Rectal Cancer Surgery

A study testing Single-port robotic surgery and Multi-port robotic surgery in people with Rectal Cancer and Surgery, run by Ruijin Hospital at 4 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is designed to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Rectal Cancer, Surgery
What is being tested?
Single-port robotic surgery and Multi-port robotic surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
4 sitesChina
Study dates
May 2025to Jun 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years < age ≤80 years
  • Tumor located in the mid to high rectum (lower edge of tumor ≥ 5 cm from anal verge)
  • Pathological rectal carcinoma
  • Clinically diagnosed c/ycT1-3N0-1M0 lesions according to the 8th Edition of AJCC Cancer Staging Manual
  • Tumor size of 10 cm or less
  • No history of other malignant tumors
Show all 9Show fewer
  • ECOG score is 0-1
  • ASA score is Ⅰ-Ⅲ
  • Informed consent

Who cannot join

  • Body mass index (BMI) >35 kg/m2
  • Familial adenomatous polyposis (FAP)
  • Inflammatory bowel disease (IBD)
  • Multiple malignant colorectal tumors
  • Pregnant woman or lactating woman
  • Severe mental disease
Show all 11Show fewer
  • Previous gastrointestinal surgery (except appendectomy ）
  • Combination of intestinal obstruction, bleeding, perforation requiring emergency surgery
  • Requirement of simultaneous surgery for other disease
  • Serious disorders of liver and kidney function, coagulation function, or severe underlying diseases that cannot tolerate the surgery.
  • Patients or family members who cannot understand the study program.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ren Zhao, MD, PHD contact

+8618917762018

zhaorensurgeon@aliyun.com

Kun Liu, MD contact

+8618121263082

lookiere@126.com

China4 sites

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250021

    Leping Li, MD

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang, Henan, 471003

    Jingming Zhai, MD

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 201801

    Kun Liu, MD, +8618121263082, lookiere@126.com

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

    Xian Shen, MD

Other trials in China

About this study

Official title: Safety and Efficacy Study of Single-port Robotic Versus Multi-port Robotic Radical Rectal Cancer Surgery: A Multi-center, Prospective, Open Label, Non-inferiority, Randomized Controlled Trial

This study is designed to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.

Read the detailed description

Surgical robots were born in the 1980s and have the advantages of being precise, flexible, less invasive and remotely operable than traditional surgical methods. The single-port robot is a further extension of minimally invasive surgery by placing multiple instruments through a single incision. Most studies have reported on the perioperative outcomes of robotic versus conventional laparoscopic surgery in the treatment of colorectal cancer. However, there are limited data comparing the perioperative outcomes of single-port robotics and multi-port robotics in the treatment of colorectal cancer，especially in rectal cancer surgery. The purpose of this study is to evaluate the safety and efficacy of single-port robotic surgery compared to multi-port robotic surgery for rectal cancer.

Being tested
Single-port robotic surgery, Multi-port robotic surgery
Keywords
Rectal Cancer, Robotic Surgery
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Single-port robotic surgeryProcedure or surgery

    Also called SPRS

    In this group, patients will be operated using a single-port surgical robot system. In the single-port configuration, a four-channel trocar shall be used. The surgical tools are steered through the curved access channels in the trocar to enter a patient's abdomen. The surgical procedure followed the principle of total mesorectal excision.

  • Multi-port robotic surgeryProcedure or surgery

    Also called MPRS

    In this group, patients will be operated using a multi-port surgical robot system. Surgical instruments enter the abdominal cavity through 4 separate trocars. The surgical procedure followed the principle of total mesorectal excision.

Study groups in NCT06943690
Study groupRoleWhat they receive
Single-Port Robotic SurgeryExperimentalPatients with rectal cancer undergo single-port robotic surgery.
Receives: Procedure: Single-port robotic surgery
Multi-Port Robotic SurgeryActive comparatorPatients with rectal cancer undergo multi-port robotic surgery.
Receives: Procedure: Multi-port robotic surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surgical success rate

    Proportion of robotic procedures not converted to laparoscopic or open surgery

    Measured: intraoperative

Secondary outcomes (14)

  1. Operative time

    Operative time（minutes）

    Measured: intraoperative

  2. Intraoperative blood loss

    Estimated blood loss（milliliters，ml）

    Measured: intraoperative

  3. Incision length

    Incision length（centimeters，cm）

    Measured: intraoperative

  4. Total incision length

    The sum of all incision lengths（centimeters，cm）

    Measured: intraoperative

  5. Length of stay

    The postoperative day when patients complied with the predefined discharge

    Measured: 1-30 days after surgery

  6. Postoperative recovery course

    Time to first ambulation, flatus, liquid diet and semi-liquid diet （hours after surgery）

    Measured: 1-14 days after surgery

  7. Early morbidity rate

    morbidity rate 30 days after surgery

    Measured: 30 days after surgery

  8. Pain score

    postoperative pain is recorded using the visual analog scale (VAS) pain score （0-10 points）tool on postoperative day 1, 2, 3

    Measured: 1-3 days after surgery

  9. Tumor size

    The diameter of tumors（centimeters，cm）

    Measured: 14 days after surgery

  10. Incisal margin

    Length of proximal and distal margin （centimeters，cm）

    Measured: 14 days after surgery

  11. Lymph node detection

    Lymph nodes harvested（numbers）

    Measured: 14 days after surgery

  12. Cosmetic effect

    European Organization for Research and Treatment of Cancer Quality of Life

    Measured: 1 month, 6 months and 1 year after surgery

  13. The quality of life-Colorectal

    European Organization for Research and Treatment of Cancer Quality of Life

    Measured: 1 month, 6 months and 1 year after surgery

  14. disease free survival rate

    1-year disease free survival rate

    Measured: 12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06943690
Sponsor's protocol ID
RASILS-01
Status last verified
Apr 2025
First submitted
17 Apr 2025
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guo Z, Shi Y, Song Z, Jia W, Wang S, Zhang Y, Ji X, Liu K, Zhang T, Cheng X, Zhao R. Single-incision robotic assisted surgery: a nonrandomized cohort pilot study on a novel surgical platform in colorectal surgery. Int J Surg. 2023 Nov 1;109(11):3417-3429. doi: 10.1097/JS9.0000000000000612.

    PubMed 37526117

Questions about this trial

What is this clinical trial studying?

A study testing Single-port robotic surgery and Multi-port robotic surgery in people with Rectal Cancer and Surgery, run by Ruijin Hospital at 4 sites 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 9 inclusion and 11 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: opening soon, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 Ren Zhao, MD, PHD (+8618917762018, zhaorensurgeon@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical success rate (time frame: intraoperative). 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 NCT06943690, 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 24 Apr 2025.

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