A Prospective Single-center Randomized Controlled Trial of Robotic Surgery with Transrectal Resection Specimens (NOSES-IV) and Traditional Assisted Robotic Surgery for the Treatment of High Rectal and Sigmoid Colon Cancer

Launched by NANCHANG UNIVERSITY · Mar 26, 2025

Keywords

ClinConnect Summary

This is a randomized, single-center clinical trial in NanChang, China, testing two robotic surgery methods for high rectal cancer and sigmoid colon cancer. The study compares NOSES-IV, a newer approach where the tumor piece is removed through the anus after robotic surgery, with the traditional robotic method that removes the tumor through an abdominal incision. About 100 adults are planned to participate, and people will be randomly assigned to one of the two procedures. The trial is currently enrolling by invitation and is led by Professor Taiyuan Li at Nanchang University.

Who can join: adults 18 to about 85 years old with a confirmed rectal adenocarcinoma that MRI shows as stage cT1-3NxM0 and a tumor up to about 5 cm. They should be in good enough health for surgery (ECOG performance status 0-2) and able to sign consent. Exclusions include having multiple colorectal cancers, recurrent disease, prior neoadjuvant therapy, emergency obstruction or bleeding, prior anal surgery, BMI of 30 or higher, or severe mental illness. Participants can expect a robotic operation with either NOSES-IV or the traditional abdominal approach, followed by measuring complications within about 1 month after surgery, plus secondary outcomes like operative time, blood loss, hospital stay, and pain scores at 1 week.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1) The age is more than 18 years old and less than or equal to 85 years old 2) Eastern Cooperative Oncology Group score ≤2 3) Preoperative pathological diagnosis of rectal adenocarcinoma 4) cT1-3NxM0 rectal cancer defined by preoperative contrast-enhanced MRI 5) The maximum diameter of tumor ≤5cm on preoperative enhanced MRI 6) The body can tolerate the operation and sign the informed consent
• Exclusion Criteria:
• • 1) multiple primary colorectal cancer 2) recurrent rectal cancer 3) preoperative neoadjuvant chemoradiotherapy 4) complicated with intestinal obstruction or intestinal bleeding requiring emergency surgery 5) previous anal surgery history 6) BMI≥30kg/m2 7) severe mental illness