Robotic Natural Orifice Specimen Extraction Surgery Compared to Robotic Assisted Surgery for Median Rectal Cancer
Launched by NANCHANG UNIVERSITY · Jun 11, 2024
Trial Information
Current as of October 31, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This trial is testing two robotic surgery methods for middle rectal cancer. One method uses a robotic system and removes the tumor through the anus (no big abdominal incision), called robotic natural orifice specimen extraction surgery (NOSES-II). The other method uses a robotic approach with the usual abdominal incision to remove the tumor. The study is randomized and aims to enroll about 100 adults. The main question is whether NOSES-II is safe and feasible, by looking at the overall rate of complications within about one month after surgery, including more serious problems and any issues with reconnecting the bowel.
Eligible participants are adults roughly 18 to 85 years old with a confirmed rectal cancer that is up to 5 cm on MRI, no distant spread, and a reasonably good health status (ECOG 0-2). They must be able to tolerate surgery and provide informed consent. Exclusions include having other colorectal cancers, cancer recurrence, needing emergency surgery, prior anal surgery, BMI 30 or higher, or certain mental health issues. The trial is being conducted at The First Affiliated Hospital of Nanchang University in China and is currently enrolling by invitation. Additional short-term outcomes will also be measured, such as operative time, blood loss, length of hospital stay, and pain after surgery. The study will not share individual patient data.
Gender
ALL
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
About Nanchang University
Nanchang University is a prestigious research institution located in Nanchang, China, known for its commitment to advancing medical science and improving healthcare outcomes. As a clinical trial sponsor, the university leverages its robust academic resources and interdisciplinary expertise to conduct innovative research that addresses critical health challenges. By fostering collaboration among researchers, clinicians, and industry partners, Nanchang University aims to facilitate the development of new therapies and treatment modalities, ensuring rigorous adherence to ethical standards and regulatory compliance throughout the trial process. The university's dedication to evidence-based medicine and patient-centered research underscores its role as a leader in the clinical research landscape.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nanchang, Jiangxi, China
Patients applied
Trial Officials
shanping Ye
Study Chair
The First Affiliated Hospital of Nanchang University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported