The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
NCT Number: NCT02435758
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. PANP (pelvic autonomic nerve preservation) 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 (O-PANP-TME) or laparoscopic PANP TME surgery (L-PANP-TME).
In the early stage of work, the investigators performed preservation of Denovilliers' fascia in L-PANP-TME to discuss the protection of urinary and sexual function of male mid-low rectal cancer patients. The results showed that preservation of Denovilliers' fascia in L-PANP-TME significantly decreased incidence of urinary and sexual function disorder. In order to further confirm the early work, the investigators design a multicenter randomized controlled clinical trial to compare differences in urinary and sexual function protection and long-term outcomes between preservation and excision of Denovilliers' fascia in L-PANP-TME.
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Notify Me20 year–71 year
Male
Interventional
Not applicable
Guangzhou, Guangdong, 510630, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exit criteria:
In this group, the patients accept L-PANP surgery, as well as preservation of Denonvilliers Fascia
Time frame: 14 days
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Time frame: 14 days
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
Time frame: 30 days
incidence of postoperatvie complications
Time frame: 36 months
3-year overall survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 30 days
incidence of postoperatvie deaths
Time frame: 60 months
5-year overall survival rate
Time frame: 60 months
5-year recurrence pattern
Time frame: 36 months
3-year disease free survival rate
Time frame: 60 months
5-year disease free survival rate
Time frame: 12 months
International questionnaire of erectile function-5 (IIEF-5)
Time frame: 12 months
Ejaculation function classification
Time frame: 12 months
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Third Affiliated Hospital, Sun Yat-Sen University
Other
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