RecruitingNCT05245565

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

Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer: A Multicenter Prospective Cohort Study


Sponsor

Shanghai 10th People's Hospital

Enrollment

120 participants

Start Date

May 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

RATIONALE: Colorectal cancer is one of the most common cancers. However, approaches to minimize surgical trauma, preserve anal function, avoid abdominal stoma, and improve quality of life for patients with ultralow rectal cancers were limited. Thus, new technologies are urgently needed to improve the anal preservation rate, reduce the incidence of anastomotic leakage and improve postoperative anal function in patients with ultralow rectal cancer. PURPOSE: This one-arm multicenter prospective cohort study aims to collect the data of patients with ultralow rectal cancer who undergo sphincter-preserving surgeries, including modified PPS and conventional surgeries, then compare the effects of different operations on clinical outcomes and to see the efficacy and safety of modified PPS surgery when compared with conventional procedures in the treatment of ultralow rectal cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a modified surgical technique for very low rectal cancer — cancers located close to the anal opening. The goal is to remove the cancer while preserving the muscles that control bowel movements (the sphincter), so patients can avoid a permanent colostomy bag. **You may be eligible if...** - You have been newly diagnosed with rectal cancer (adenocarcinoma) - The bottom edge of your tumor is less than 3 cm from the dentate line (the boundary between different tissue types inside the anus) - Your cancer is at an early to moderate stage (T3 or less) **You may NOT be eligible if...** - The tumor is less than 1 cm from the dentate line - Your cancer is locally advanced - Your cancer has spread to other parts of the body or has come back after prior treatment - You have another cancer at the same time - You have uncontrolled medical conditions - You have impaired anal muscle function before surgery - You have a bowel obstruction or perforation from the cancer - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

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NCT05245565


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