Advanced Cancer, Rectal Cancer
Conditions
Keywords
Urogenital Function, Denonvilliers' Fascia
Brief summary
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.
Interventions
PROCEDUREComplete Preservation of Denonvilliers' Fascia
Patients accept L-PANP surgery with complete preservation of Denonvilliers Fascia
Sponsors
Sixth Affiliated Hospital, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 71 Years
Healthy volunteers
No
Inclusion criteria
1. Pathological diagnosis of rectal adenocarcinoma; 2. Preoperative staging cT3-4 and or N+，M0 rectal cancer (AJCC- 7th); 3. Non-anterior wall, mid-low rectal cancer from 0 to 12 cm from the anal verge measured by rigid proctoscope; 4. R0 surgical results is expected by transabdominal or transanal TME/TSME; 5. 18 \< age (years) \< 71, informed consent; 6. Normal erection function (IIEF-5\>21), ejaculation function grading as I level, FSFI \> 26, normal urinary function (Bladder residual urine\<100ml); 7. Preoperative ASA grade I \ III, no serious systemic disease;
Exclusion criteria
1. Preoperatively confirmed peritoneum or distant metastasis; 2. Intraoperative confirmed invasion of surrounding tissues or organs, cannot be R0 resected; 3. With other malignant diseases; 4. With acute ileus, perforation or hemorrhage,need emergency surgery; 5. Critical organs dysfunction, unable to tolerate laparoscopic surgery; 6. With severe mental illness, cannot be evaluated;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of sexual dysfunction | 1 month | IIEF-5(International questionnaire of erectile function-5), Ejaculation function and FSFI questionnaires are used to assess sexual function |
| Incidence of urinary dysfunction | 1 month | IPSS(International prostate symptom score), ICIQ, bladder residual urine volume and urodynamic study are used to assess urinary function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life assessed with GIQLI questionnaires | 1month | GIQLI questionnaires are used to assess quality of life |
| 1-year local recurrence | 1 year | 1-year local recurrence |
| Incidence of sexual dysfunction | 9 months | IIEF-5, Ejaculation function and FSFI questionnaires are used to assess sexual function |
| Positive Circumferential Resection Margin Rate | 1 week | Positive Circumferential Resection Margin Rate |
| 1-year overall survival rate | 1 year | 1-year overall survival rate |
| Incidence of urinary dysfunction | 9 months | IPSS, ICIQ questionnaires, bladder residual urine volume and urodynamic study are used to assess urinary function |
Countries
China
Contacts
Primary ContactBing Zeng, M.D.
Outcome results
None listed