Tubeless NOSES Versus Laparoscopic Radical Resection for Rectosigmoid Cancers

Launched by SIXTH AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Jul 28, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to perform surgery for patients with rectosigmoid cancers, which are cancers located in the lower part of the large intestine. The researchers want to compare a new method called Tubeless NOSES, which avoids the need for external tubes, with the traditional laparoscopic radical resection, which is a common surgical approach that uses small incisions and sometimes requires tubes for drainage. The goal is to see how these methods perform in the short and long term, focusing on recovery and outcomes for patients.

To participate in this trial, patients need to be between 18 and 75 years old and have confirmed rectosigmoid cancer that hasn’t spread extensively. They should also be in good health overall, with no serious heart, lung, or liver problems, and a body mass index (BMI) of 30 or less. If eligible, participants can expect to have their surgery assigned randomly to either method and will need to attend follow-up appointments to monitor their recovery. This trial is currently recruiting, so there’s an opportunity for eligible patients to contribute to important research in cancer treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically or cytologically confirmed Rectosigmoid Cancers
• • 2. Clinical stage at T 1-3 N0-2 M0
• • 3. Tumors on peritoneal reflection，Tumor size is no more than 3 cm
• • 4. Eastern Cooperative Oncology Group (ECOG) scale is 0-2
• • 5. American Society of Anesthesiologists (ASA) score is Ⅰ-Ⅲ
• • 6. BMI ≤ 30 kg/m2
• • 7. Subjects must be willing and able to comply with scheduled visits, treatment schedule,and laboratory testing.
• Exclusion Criteria:
• • 1. Heart, lung, liver or renal or any organ function that are intolerance for surgery
• • 2. History of treated colorectal malignant disease
• • 3. Subjects with medical condition, such as intestinal obstruction, intestinal perforation, bleeding, requires emergency surgery
• • 4. Subjects with previous malignancies
• • 5. History of inflammatory bowl disease(IBD) or familial adenomatous polyposis (FAP)
• • 6. Treatment with any other clinical trial within 28 days prior to randomization
• • 7. History of severe mentally disease
• • 8. pregnant or lactating women
• • 9. The researchers believe that the patients are unsuitable to participate in the researchers with other cases.