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

This study aimed to compare the short-term efficacy of robotic radical resection of high rectal cancer and sigmoid colon cancer (NOSES-IV) with transrectal resection specimens and traditional robotic surgery in the treatment of high rectal cancer and sigmoid colon cancer. At the same time, the safety and advantages of robotic radical resection of high rectal cancer and sigmoid colon cancer (NOSES-IV) with transrectal resection specimens and traditional robotic surgery in the treatment of high rectal cancer and sigmoid colon cancer were compared.

Study Overview

• Status: Enrolling by invitation
• Conditions: Robotic Surgery; Natural Orifice Specimen Extraction Surgery; Short-term Outcomes
• Intervention / Treatment: Procedure: robotic natural orifice specimen extraction surgery; Procedure: robotic transabdominal specimen extraction surgery

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Nanchang, China
    • the First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi 330000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NOSES-IV Group; After the body is free, the tumor segment of the bowel is pulled out through the anus. Excise the tumor segment of the colon outside the anus.	Procedure: robotic natural orifice specimen extraction surgery; After the rectum and its mesorectum were dissociated, the rectum was transected at 2 cm below the tumor by using a linear stapler. Then the rectal stump was incised and disinfected with iodophor, the protective sleeve was placed into the abdominal cavity through the assistant hole. An assistant delivered oval forceps into the pelvic cavity through the anus and used oval forceps to grip one end of the protective sleeve. Then slowly pulled out the protective sleeve. Eventually, one end of the protective sleeve was placed inside the abdominal cavity and the other outside the anus, completely covering the rectal stump and the perianal area. Tumor was pulled out of the rectal stump, then the colon was then disconnected at 10 cm above the tumor. The anvil was placed into the stump of the sigmoid colon and disinfected with iodophor, and then the anvil was delivered into the abdominal cavity. Place a circular stapler through the anus for end-to-end anastomosis of the rectum and sigmoid colon.
Sham Comparator: non-NOSES Group; After internal mobilization, the tumor segment of the bowel was removed through an abdominal incision. Excise the tumor segment of the bowel outside the incision.	Procedure: robotic transabdominal specimen extraction surgery; After the rectum and its mesorectum were dissociated, the rectum was transected at 2 cm below the tumor by using a linear stapler. Take a 6cm incision through the rectus abdominis muscle in the lower left abdomen and place an incision protective cover. Cut off the intestinal tube 10cm from the upper edge of the tumor and place a stapler base. The rectal stump was sutured with purse-string suture. Place a circular stapler through the anus for end-to-end anastomosis of the rectum and sigmoid colon. After completion of digestive tract reconstruction. The pelvic and abdominal cavities were washed repeatedly with normal saline until there were no blood remained. Close the abdominal cavity layer by layer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of all complications	incidence rate	1 months after surgery
The rate of all complications (Clavien-Dindo grade ≥ III )	incidence rate	1 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	minutes	Intraoperative
estimation of blood loss	milliliters	Intraoperative
postoperative hospital stay	days	1 day after operation
visual analogue pain score	score	1 weeks after surgery

Collaborators and Investigators

• Sponsor: Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Sigmoid Diseases; Colonic Neoplasms; Sigmoid Neoplasms
• Other Study ID Numbers: ZL078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No