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

Robotic Clinical Trial

Official title:

the First Affiliated Hospital of Nanchang University

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06454201
• Other study ID #: IIT2024013
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Nanchang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Natural Orifice Specimen Extraction Surgery
• Rectal Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of all complications	incidence rate	1 months after surgery
Primary	The rate of all complications (Clavien-Dindo grade = III )	incidence rate	1 months after surgery
Primary	The rate of anastomotic complications	Anastomotic leakage and anastomotic bleeding	1 months after surgery
Secondary	operative time	minutes	Intraoperative
Secondary	estimation of blood loss	milliliters	Intraoperative
Secondary	postoperative hospital stay	days	1 day after operation
Secondary	visual analogue pain score	score	1 weeks after surgery