To hear about similar clinical trials, please enter your email below
Trial Title:
Robotic Natural Orifice Specimen Extraction Surgery Compared to Robotic Assisted Surgery for Median Rectal Cancer
NCT ID:
NCT06454201
Condition:
Natural Orifice Specimen Extraction Surgery
Middle Rectal Cancer
Robotic
Short-term Outcomes
Conditions: Official terms:
Rectal Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
robotic natural orifice specimen extraction surgery
Description:
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.
Arm group label:
robotic natural orifice specimen extraction surgery for middle rectal cancer
Intervention type:
Procedure
Intervention name:
robotic transabdominal specimen extraction surgery
Description:
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.
Arm group label:
robotic transabdominal specimen extraction surgery for middle rectal cancer
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.
Criteria for 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 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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330000
Country:
China
Start date:
January 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Nanchang University
Agency class:
Other
Source:
Nanchang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06454201
