Conformal Sphincter-Preservation Operation Versus InterSphincteric Resection on Anal Function in Low Rectal Cancer

Launched by CHANGHAI HOSPITAL · Aug 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying two different surgical approaches for patients with low rectal cancer: the Conformal Sphincter-Preservation Operation (CSPO) and the InterSphincteric Resection (ISR). The goal is to understand how each method affects anal function, urinary function, quality of life, safety during surgery, and cancer outcomes. By comparing these two surgical options, the researchers hope to provide better information for patients and doctors when deciding on treatment.

To participate, individuals must be between 18 and 75 years old with specific types of rectal cancer that meet certain criteria, such as the tumor being a certain size and depth. Participants should have normal anal function before surgery and agree to join the study by signing an informed consent form. Those with other cancers, severe health issues, or who are pregnant or breastfeeding are not eligible. If someone qualifies and chooses to take part, they can expect to be closely monitored throughout the study to assess their recovery and overall health after surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age: 18-75 years;
• • 2. Pathologically confirmed: moderately \& well-differentiated rectal cancer;
• • 3. Low rectal cancer: lower edge of tumor ≦5cm from anal verge or ≦2cm from dentate line;
• • 4. Tumor diameter: ≤3cm or \<1/3 bowel circumference;
• • 5. Tumor infiltration depth: cT1-2, Bordeaux/Rullier classification: type II-III;
• • 6. Locally progressive rectal cancer (cT1-4N0-2M0): significant tumor downstaging and downgrading after preoperative neoadjuvant therapy, meeting the above criteria;
• • 7. ASA score: I-III and ECOG score: 0-1;
• • 8. Undergo elective TME for colorectal or colorectal-anal canal anastomosis;
• • 9. Normal preoperative anal function: Wexner score \<10, LARS score \<20;
• • 10. Agree to participate in the clinical trial and sign an informed consent form.
• Exclusion Criteria:
• • 1. Combination of synchronous or metachronous (within 5 years) malignant tumors;
• • 2. Combined distant metastasis of the tumor;
• • 3. Combined intestinal obstruction, intestinal perforation, or intestinal bleeding requiring emergency surgery;
• • 4. Combined psychiatric disorders that do not allow them to understand and participate in the study;
• • 5. Combined systemic diseases that cannot tolerate surgery;
• • 6. Women who are pregnant or breastfeeding;
• • 7. Other reasons, judged by the investigator, for not being suitable for participation in this clinical trial.