Status:
UNKNOWN
Complete Versus Partial Preservation of Denonvilliers' Fascia on Urogenital Function in Locally Advanced Rectal Cancer
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Rectal Cancer
Advanced Cancer
Eligibility:
All Genders
18-71 years
Phase:
NA
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 dysfunc...
Eligibility Criteria
Inclusion
- Pathological diagnosis of rectal adenocarcinoma;
- Preoperative staging cT3-4 and or N+，M0 rectal cancer (AJCC- 7th);
- Non-anterior wall, mid-low rectal cancer from 0 to 12 cm from the anal verge measured by rigid proctoscope;
- R0 surgical results is expected by transabdominal or transanal TME/TSME;
- 18 \< age (years) \< 71, informed consent;
- Normal erection function (IIEF-5\>21), ejaculation function grading as I level, FSFI \> 26, normal urinary function (Bladder residual urine\<100ml);
- Preoperative ASA grade I \~ III, no serious systemic disease;
Exclusion
- Preoperatively confirmed peritoneum or distant metastasis;
- Intraoperative confirmed invasion of surrounding tissues or organs, cannot be R0 resected;
- With other malignant diseases;
- With acute ileus, perforation or hemorrhage,need emergency surgery;
- Critical organs dysfunction, unable to tolerate laparoscopic surgery;
- With severe mental illness, cannot be evaluated;
Key Trial Info
Start Date :
April 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT04672603
Start Date
April 8 2021
End Date
May 1 2025
Last Update
April 29 2021
Active Locations (1)
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1
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510655