Multicenter Study on Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal Cancer
- Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Enrollment
- 262
- Locations
- 1
- Primary Endpoint
- Sexual function
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Investigators
Hongbo Wei
Assistant to the Dean
Third Affiliated Hospital, Sun Yat-Sen University
Eligibility Criteria
Inclusion Criteria
- •Male, 20 \< age (years) \< 71, informed consent;
- •Pathological diagnosis of rectal adenocarcinoma;
- •Tumors from anal edge 6 \~ 12 cm (measured by rigid proctoscope);
- •Preoperative staging T1-4 (T1-2 for anterior rectal wall) N0-2M0 rectal cancer (AJCC- 7th);
- •R0 TME surgical results is expected;
- •Preoperative ECOG physical status score 0/1;
- •Preoperative ASA grade I \~ III;
- •Normal urinary function (Bladder residual urine\<100ml), normal erection function (IIEF-5\>21) and ejaculation function grading as I level.
Exclusion Criteria
- •Complicated with acute ileus, perforation or hemorrhage;
- •Tumors with extensive invasion of surrounding tissues, TME not applicable; Imaging examination in regional integration intumescent lymph nodes (maximum diameter 3 cm or higher);
- •With other malignant diseases or with other malignant disease within 5 years; With other diseases need surgery;
- •A history of abdominal and pelvic major operation;
- •People with severe mental illness, or cannot be evaluated due to cultural or psychological factors;
- •No sexual life;
- •Critical organ dysfunction, unbearable surgery;
- •Unstable angina, myocardial infarction, cerebral infarction or hemorrhage within 6 months;
- •Systemic corticosteroids or immunosuppressive medication history within 1 month;
- •Pre-existent true incontinence or severe stress urinary incontinence.
Outcomes
Primary Outcomes
Sexual function
Time Frame: 14 days
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
Urinary function
Time Frame: 14 days
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Secondary Outcomes
- 3-year recurrence pattern(36 months)
- Mortality(30 days)
- Morbidity(30 days)
- Sexual function(12 months)
- Urinary function(12 months)
- 5-year recurrence pattern(60 months)
- 3-year overall survival rate(36 months)
- 3-year disease free survival rate(36 months)
- 5-year disease free survival rate(60 months)
- 5-year overall survival rate(60 months)