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

Not Applicable

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

• Registration Number: NCT06454201
• Lead Sponsor: Nanchang University

Brief Summary

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.

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 Timeline

• Study Start: 2023-01-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-11
• Last Update Submitted: 2024-06-11
• Study First Posted: 2024-06-12
• Last Update Posted: 2024-06-12
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
robotic transabdominal specimen extraction surgery for middle rectal cancer	robotic transabdominal specimen extraction surgery	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.
robotic natural orifice specimen extraction surgery for middle rectal cancer	robotic natural orifice specimen extraction surgery	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.

Primary Outcome Measures

Name	Time	Method
The rate of all complications (Clavien-Dindo grade ≥ III )	1 months after surgery	incidence rate
The rate of anastomotic complications	1 months after surgery	Anastomotic leakage and anastomotic bleeding
The rate of all complications	1 months after surgery	incidence rate

Secondary Outcome Measures

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

Trial Locations

Locations (1)

the First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China