Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer

Launched by SHANGHAI 10TH PEOPLE'S HOSPITAL · Feb 16, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new type of surgery called modified Precision Functional Sphincter-Preserving Surgery (PPS) for patients with ultralow rectal cancer. The goal is to see if this surgery can help patients keep their anal function, reduce complications like leakage, and avoid the need for a colostomy bag, which is an opening made in the abdomen for waste to leave the body. Researchers will compare the results of this new surgical approach with traditional methods to find out which one works better in terms of recovery and quality of life.

To participate in this trial, patients must have a confirmed diagnosis of rectal cancer that is located close to the anal area but not too close (at least 1 cm away), and the cancer should be at an early stage (T3 or less). Patients aged 65 and older, regardless of gender, are eligible to join. Participants will undergo the surgery and will be monitored for their recovery, helping doctors gather important information about the benefits and safety of this new surgical technique. If you or a loved one is considering joining, it’s a chance to contribute to research that could improve treatment options for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Histological proof of newly diagnosed primary adenocarcinoma of the rectum
• • 2. The lower edge of tumor \< 3 cm from the dentate line
• • 3. Clinical T stage ≤ T3
• Exclusion Criteria:
• • 1. The lower edge of tumor \< 1 cm from the dentate line
• • 2. Locally advanced stage of tumor
• • 3. Presence of metastatic disease or recurrent rectal tumor
• • 4. Concomitant malignancies
• • 5. Concurrent uncontrolled medical conditions
• • 6. Impaired anal function before surgery
• • 7. Presence of acute bowel obstruction or bowel perforation caused by cancer
• • 8. Pregnancy or breast feeding