Total mesorectal resection (TME) is the standard surgical method for locally advanced rectal cancer, which significantly reduces the local recurrence rate. However, the incidence of urogenital dysfunction is higher. Studies found that Denonvilliers' Fascia contains autonomic nerves that may regulate urogenital function, while traditional TME surgery resects part of it. Recent Studies found that complete preservation of Denonvilliers' Fascia could improve urogenital in selected patients with rectal cancer. Locally advanced patient (T3-4 and/or N+, M0) accounts for a high proportion of mid-low rectal cancer. However, whether these patients can benefit from it has not fully been demonstrated. This project conducts a multi-center randomized controlled study to evaluate the effects of complete preservation and partial preservation of Denonvilliers' Fascia on postoperative urogenital function of locally advanced non-anterior mid-low rectal cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
214
Patients accept L-PANP surgery with complete preservation of Denonvilliers Fascia
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGIncidence of sexual dysfunction
IIEF-5(International questionnaire of erectile function-5), Ejaculation function and FSFI questionnaires are used to assess sexual function
Time frame: 1 month
Incidence of urinary dysfunction
IPSS(International prostate symptom score), ICIQ, bladder residual urine volume and urodynamic study are used to assess urinary function
Time frame: 1 month
Incidence of sexual dysfunction
IIEF-5, Ejaculation function and FSFI questionnaires are used to assess sexual function
Time frame: 9 months
Incidence of urinary dysfunction
IPSS, ICIQ questionnaires, bladder residual urine volume and urodynamic study are used to assess urinary function
Time frame: 9 months
Quality of life assessed with GIQLI questionnaires
GIQLI questionnaires are used to assess quality of life
Time frame: 1month
Quality of life assessed with GIQLI questionnaires
GIQLI questionnaires are used to assess quality of life
Time frame: 9 months
1-year local recurrence
1-year local recurrence
Time frame: 1 year
1-year overall survival rate
1-year overall survival rate
Time frame: 1 year
Positive Circumferential Resection Margin Rate
Positive Circumferential Resection Margin Rate
Time frame: 1 week
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