Rectal Cancer Clinical Trial
Official title:
Single Center Study of Intraoperative Radiotherapy for Middle and Low Rectal Cancer in the Standard of Peritoneal Inversion Rectal Cancer.
To study the application of Intersphincteric Resection（ISR）combined with intraoperative
radiation therapy(IORT) for ultra-low rectal cancer,and to broaden the surgical indications
of Intersphincteric Resection（ISR.
The study is aimed to assess the postoperative acute complication and the short-term acute
efficacy on the patients with middle and low rectal cancer by treated with intraoperative
radiotherapy,especially those with peritoneal inversion rectal cancer.
Abstract objective: To study the application of Intersphincteric Resection（ISR）combined with
intraoperative radiation therapy(IORT) for ultra-low rectal cancer,and to broaden the
surgical indications of Intersphincteric Resection（ISR）.
Methods: Patients, who were diagnosed with ultra-low rectal cancer and had strong desire of
preserving anal function, will take part in the research,whose tumor invading the levator ani
muscle or above, the diameter less than 6cm, the lower tumor margin away from the anal verge
by less than 5cm and away from the dentate line by less than 3cm.They will undergo total
mesorectal excision(TME) and ISR combined with IORT and prophylactic ileostomy.
Outcomes Measures:The evaluation of short term effects includes complications such as
anastomotic leakage, acute radiation injury ,urinary dysfunction ,dysfunction of anal
sphincter ,sexual dysfunction ,local recurrence , total life expectancy and expectancy
without metastasis. The postoperative pathological examination reported to be moderately
differentiated adenocarcinoma .We wili assess their postoperative acute complications and
short-term efficacy .Their time of follow up visit wil be 1 year or more.
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