Comparison of Postoperative Anal Function Between Parks and Bacon Techniques in Low Rectal Cancer

Launched by SIXTH AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Jul 12, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to compare two different surgical methods for patients with low rectal cancer: the Parks operation and the Bacon operation. Both surgeries aim to help patients regain anal function after treatment, which is important for their quality of life. The main goal is to see if there is a difference in how well patients can control their bowel function one year after either type of surgery.

To be eligible for this study, patients need to be between 18 and 75 years old and have been diagnosed with rectal cancer that is close to the anal area. They should not have any serious complications or other cancers that could affect the surgery. Participants will be randomly assigned to receive either the Parks or the Bacon operation and will be monitored for a year to evaluate their recovery. This trial is currently recruiting, and it’s an opportunity for patients to contribute to important research that may help improve surgical outcomes and quality of life for others facing similar challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Men or women, aged between 18 and 75 years;
• • 2. Pathological diagnosis of rectal cancer before operation, with the distance from the lower edge of the tumor to the dentate line ≤ 3cm by MR imaging;
• • 3. No local complications (including complete/ incomplete obstruction, active bleeding, local invasion of sphincter or levator ani, etc.) before operation;
• • 4. Suitable for anal preservation surgery discussed by MDT;
• • 5. Adequate bone marrow, liver, renal and cardiac function meeting the requirements of surgery and anesthesia;
• • 6. R0 resection is expected technically;
• • 7. Provision of written informed consent.
• Exclusion Criteria:
• • 1. Previous history of malignant colorectal tumors;
• • 2. Complications such as obstruction and gastrointestinal bleeding that need an emergency operation;
• • 3. Unachievable R0 resection due to invasion of adjacent organs by primary tumor;
• • 4. Multiple primary tumors;
• • 5. History of other malignancy;
• • 6. Participation in other clinical trials within the previous 4 weeks of enrollment;
• • 7. ASA physical status score ≥ IV level and/or ECOG performance status ≥ 2;
• • 8. Intolerance of surgery due to liver, renal, cardiopulmonary or coagulation dysfunction, or underlying diseases;
• • 9. History of serious mental disorders;
• • 10. Women in pregnancy or lactation period;
• • 11. Uncontrolled infection before operation;
• • 12. Unsuitable to be included due to other clinical and laboratory conditions by the judgement of investigators.