TME (Total mesorectum excision) is the golden standard of radical resection for mid-low rectal cancer. However, the damage of pelvic autonomic nerve following with TME principle will lead to high incidence of urinary and sexual function disorder. Open PANP (pelvic autonomic nerve preservation) TME surgery played a role in decreasing incidence of urinary and sexual function disorder. However, 32%-44% patients still suffered from urinary and sexual function disorder when underwent Open PANP TME surgery (O-PANP-TME). Laparoscopy-assisted TME surgery (L-TME) is applied wildly nowadays. In the early stage of work, we performed laparoscopy-assisted PANP TME surgery (L-PANP-TME) to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm our early work, we design a multiple-center randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between L-PANP-TME and O-PANP-TME.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
667
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITING3-year disease free survival rate
Time frame: 36 months
Urinary function
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Time frame: 30 days
Sexual function
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
Time frame: 30 days
5-year disease free survival rate
Time frame: 60 months
Urinary function
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Time frame: 36 months
Sexual function
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
Time frame: 36 months
Morbidity
Time frame: 30 days
3-year overall survival rate
Time frame: 36 months
Mortality
Time frame: 30 days
Morbidity
Time frame: 36 months
Mortality
Time frame: 36 months
5-year overall survival rate
Time frame: 60 months
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