Clinical trial NCT06454201: Robotic Natural Orifice Specimen Extraction Surgery Compared to Robotic Assisted Surgery for Median Rectal Cancer
Official title: the First Affiliated Hospital of Nanchang University
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Natural Orifice Specimen Extraction Surgery
Middle Rectal Cancer
Robotic
Short-term Outcomes
Lead sponsor: Nanchang University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The rate of all complications
timeFrame: 1 months after surgery
measure: The rate of all complications (Clavien-Dindo grade ≥ III )
timeFrame: 1 months after surgery
measure: The rate of anastomotic complications
timeFrame: 1 months after surgery
Secondary outcomes:
measure: operative time
timeFrame: Intraoperative
measure: estimation of blood loss
timeFrame: Intraoperative
measure: postoperative hospital stay
timeFrame: 1 day after operation
measure: visual analogue pain score
timeFrame: 1 weeks after surgery
Other outcomes:
Locations:
city: Nanchang
country: China
facility: the First Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
affiliation: The First Affiliated Hospital of Nanchang University
name: shanping Ye
role: STUDY_CHAIR
References: