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RECRUITINGINTERVENTIONAL

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

Comparison of Postoperative Anal Function Between Different Anastomosis Techniques(Parks Versus Bacon) in Low Rectal Cancer: A Prospective, Multicentric and Randomized Controlled Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this study is to compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life. The main questions it aims to answer are: the difference of anal function 1 year after surgery type of study: clinical trial participant population: patients with low rectal cancer Participants will receive Parks operation of Bacon operation If there is a comparison group: Researchers will compare Parks and Bacon operation to see if the anal function 1 year after surgery is different.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

PROCEDURE

Parks technique

compare different operational styles of low rectal cancer

PROCEDURE

Bacon technique

Bacon technique

Locations (1)

The Sixth Affiliated Hospital, Sun Yatsen University
Guangzhou, Guangdong, China