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NCT Number: NCT06943690

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Henan University of Science & Technology, Luoyang, Henan, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • ECOG score is 0-1
  • ASA score is Ⅰ-Ⅲ
  • Informed consent

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Single-port robotic surgery

Procedure

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.

Other names: SPRS

Multi-port robotic surgery

Procedure

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.

Other names: MPRS

Primary outcomes

  1. Surgical success rate

    Time frame: intraoperative

    Proportion of robotic procedures not converted to laparoscopic or open surgery

Secondary outcomes

  1. Operative time

    Time frame: intraoperative

    Operative time(minutes)

  2. Intraoperative blood loss

    Time frame: intraoperative

    Estimated blood loss(milliliters,ml)

  3. Incision length

    Time frame: intraoperative

    Incision length(centimeters,cm)

  4. Total incision length

    Time frame: intraoperative

    The sum of all incision lengths(centimeters,cm)

  5. Length of stay

    Time frame: 1-30 days after surgery

    The postoperative day when patients complied with the predefined discharge

  6. Postoperative recovery course

    Time frame: 1-14 days after surgery

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

  7. Early morbidity rate

    Time frame: 30 days after surgery

    morbidity rate 30 days after surgery

  8. Pain score

    Time frame: 1-3 days after surgery

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

  9. Tumor size

    Time frame: 14 days after surgery

    The diameter of tumors(centimeters,cm)

  10. Incisal margin

    Time frame: 14 days after surgery

    Length of proximal and distal margin (centimeters,cm)

  11. Lymph node detection

    Time frame: 14 days after surgery

    Lymph nodes harvested(numbers)

  12. Cosmetic effect

    Time frame: 1 month, 6 months and 1 year after surgery

    European Organization for Research and Treatment of Cancer Quality of Life

  13. The quality of life-Colorectal

    Time frame: 1 month, 6 months and 1 year after surgery

    European Organization for Research and Treatment of Cancer Quality of Life

  14. disease free survival rate

    Time frame: 12 months after surgery

    1-year disease free survival rate

Study contacts

Contact information is provided by the study sponsor or research team.

Kun Liu, MD

CONTACT

[email protected]

+8618121263082

Ren Zhao, MD, PHD

CONTACT

[email protected]

+8618917762018

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • First Affiliated Hospital of Wenzhou Medical University
  • Shandong Provincial Hospital
  • The First Affiliated Hospital of Henan University of Science and Technology

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 24, 2025
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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