Reconstruction of the Pelvic Floor and Perineal Wound After Rectal ELAPE

Launched by KUBAN STATE MEDICAL UNIVERSITY · Sep 28, 2023

Keywords

ClinConnect Summary

This clinical trial is studying different surgical methods to repair the pelvic floor and perineal area after a specific type of rectal cancer surgery called extralevatory abdominal-perineal extirpation. The goal is to find out which surgical technique leads to the best recovery and fewer complications for patients. In this trial, eligible participants are adults over 18 years old who have been diagnosed with lower ampullary rectal cancer and are scheduled for this surgery. Participants will be randomly assigned to one of three groups, where they will receive different types of surgical repairs.

If you choose to participate, you can expect to be monitored closely for 30 days after your surgery to assess any immediate complications, such as healing issues or infections. You will also be followed for up to a year to evaluate your long-term recovery and quality of life. The study aims to include 150 patients and is expected to finish by 2025. It's important to note that the study has been approved by an ethics committee to ensure patient safety and well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients over 18 years old suffering from cancer of the lower ampullary rectum cT1-T4N0-2M0 (according to the classification of malignant tumors TNM in the 8th edition).
• • 2. Patients with planned extralevatory abdominal-perineal extirpation of the rectum.
• • 3. Physical status of patients according to ASA classification I-II.
• • 4. Signed informed consent to participate in the study.
• Non-inclusion criteria:
• • 1. Verification of the squamous cell carcinoma diagnosis.
• • 2. The presence of acute purulent processes in the area of surgical intervention.
• Exclusion Criteria:
• • 1. Refusal to participate at any stage of the study.
• • 2. Death in the early postoperative period (up to 30 days after surgery) caused by somatic complications not associated with surgery (PATE, myocardial infarction, stroke).