A Randomized, Controlled, Multicenter, Noninferiority Clinical Study of Perioperative and Oncological Safety in Patients With Rectal Cancer

Launched by CHANGHAI HOSPITAL · Aug 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical technique called laparoscopic natural orifice specimen extraction surgery (NOSES) for patients with low rectal cancer. The goal is to see how this method compares to conventional laparoscopic surgery in terms of safety and effectiveness. Researchers will be enrolling 500 patients, dividing them into two groups: one will receive the NOSES surgery, while the other will undergo the traditional method. The main focus is on how well patients do two years after surgery, particularly in terms of staying cancer-free and managing their recovery, including effects on bowel, urinary, and sexual function.

To be eligible for this trial, participants must be between 18 and 75 years old, diagnosed with a specific type of rectal cancer, and have certain conditions that make them suitable for surgery. They should also not have severe underlying health issues or other complications. Patients who join the study can expect to be closely monitored throughout the process and will receive detailed information about their surgery and recovery. This research aims to improve treatment options for low rectal cancer, enhance patients' quality of life, and advance the field of minimally invasive surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients were aged between 18 and 75 years;
• • 2. Pathologically confirmed as adenocarcinoma;
• • 3. Colonoscopy or imaging examination confirmed that the distance between the lower edge of the tumor and the anal margin was ≤ 5cm;
• • 4. Preoperative imaging diagnosis was ct1-3nxm0;
• • 5. Preoperative colonoscopy or imaging diagnosis confirmed that the maximum diameter of the tumor was not more than 5cm;
• • 6. Body mass index (BMI) ≤ 30kg / m2;
• • 7. No local complications (no obstruction, incomplete obstruction, no massive active bleeding, no puncture Formation of pores and abscesses without invasion of adjacent organs);
• • 8. The hematopoietic functions of heart, lung, liver, kidney and bone marrow meet the requirements of surgery and anesthesia;
• • 9. Voluntary informed consent.
• Exclusion Criteria:
• • 1. Preoperative evaluation of patients with lateral lymph node metastasis;
• • 2. Previous history of malignant tumor;
• • 3. Simultaneous multiple primary colorectal cancer was diagnosed;
• • 4. There are contraindications to laparoscopic surgery, such as severe cardiopulmonary insufficiency;
• • 5. Patients who had undergone abdominal and pelvic surgery for many times or had extensive abdominal adhesions;
• • 6. Patients with intestinal obstruction, intestinal perforation, intestinal hemorrhage and other emergency operations;
• • 7. Patients with familial adenomatous polyposis, Lynch syndrome associated rectal cancer, and inflammatory bowel disease in the active phase;
• • 8. Have a history of serious mental illness;
• • 9. Pregnant or lactating women;
• • 10. Patients with uncontrolled infection before operation;
• • 11. The investigator considered that the patient should not participate in the trial.