Robotic Natural Orifice Specimen Extraction Surgery Compared to Robotic Assisted Surgery for Median Rectal Cancer

the First Affiliated Hospital of Nanchang University

The purpose of this study is to evaluate the short-term outcomes of roboric natural orifice specimen extraction surgery (NOSES-II) compared to conventional assisted robotic surgery in the treatment of median rectal cancer. The main question it aims to answer is: is it safe and feasible to perform roboric natural orifice specimen extraction surgery (NOSES-II) for median rectal cancer? What are the advantages of roboric natural orifice specimen extraction surgery (NOSES-II) compared to conventional assisted robotic surgery for median rectal cancer.

Study Overview

• Status: Completed
• Conditions: Natural Orifice Specimen Extraction Surgery; Robotic; Middle Rectal Cancer; Short-term Outcomes
• Intervention / Treatment: Procedure: robotic natural orifice specimen extraction surgery; Procedure: robotic transabdominal specimen extraction surgery

Detailed Description

A major concern to the safety of the public's health is the prevalence of colorectal cancer, which is the third most prevalent cancer and has a very high fatality rate. There are multiple treatments for rectal cancer, and surgery remains one of the most important ways. Laparoscopic surgery as a minimally invasive technique for the treatment of colorectal has been confirmed by many studies to ensure its safety and reliability. Laparoscopic surgery has also been widely used in clinical. So far, NOSES, as an emerging minimally invasive technology, has caused heated discussions in the minimally invasive surgical community, especially in rectal surgery, the emergence of NOSES, which solves the problems caused by incisions in traditional surgery, improves the mental health of patients, and has good short-term efficacy. In recent years, the popularity of robotic colorectal cancer surgery has been rising, and the concepts of radical treatment, precision, and minimally invasive have been continuously refined, and NOSES surgery, as an emerging minimally invasive technology, has further reduced the impact of surgical trauma on the body, eliminated abdominal scar incision, and avoided complications related to abdominal wall incision, and has been widely used and carried out. In addition to the benefits of patients, the high-definition lens of the robotic surgery system and the flexible robotic arm greatly remove the trembling of the operator's hand, improve the flexibility and accuracy of the operator's operation, and are more conducive to challenging operations in narrow spaces. Compared with laparoscopy, the robotic surgical system has great advantages in some aspects, such as postoperative patient urination function, sexual function, surgical complications. Robotic surgical systems, combined with NOSES, may bring greater benefits to patients.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

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 median 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: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: robotic natural orifice specimen extraction surgery for middle rectal cancer; 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: robotic transabdominal specimen extraction surgery for middle rectal cancer; 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
The rate of anastomotic complications	Anastomotic leakage and anastomotic bleeding	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
• Investigators: Study Chair: shanping Ye, The First Affiliated Hospital of Nanchang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 11, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

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

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: IIT2024013

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