Clinical trial NCT02435758: Multicenter Study on Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Sixth Affiliated Hospital, Sun Yat-sen University
name: Nanfang Hospital, Southern Medical University
First posted: 2015-05-06
Enrollment: 262
Sex: MALE
Minimum age (years): 20
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male, 20 \< age (years) \< 71, informed consent;
2. Pathological diagnosis of rectal adenocarcinoma;
3. Tumors from anal edge 6 \~ 12 cm (measured by rigid proctoscope);
4. Preoperative staging T1-4 (T1-2 for anterior rectal wall) N0-2M0 rectal cancer (AJCC- 7th);
5. R0 TME surgical results is expected;
6. Preoperative ECOG physical status score 0/1;
7. Preoperative ASA grade I \~ III;
8. Normal urinary function (Bladder residual urine\<100ml), normal erection function (IIEF-5\>21) and ejaculation function grading as I level.

Exclusion Criteria:

1. Complicated with acute ileus, perforation or hemorrhage;
2. Tumors with extensive invasion of surrounding tissues, TME not applicable; Imaging examination in regional integration intumescent lymph nodes (maximum diameter 3 cm or higher);
3. With other malignant diseases or with other malignant disease within 5 years; With other diseases need surgery;
4. A history of abdominal and pelvic major operation;
5. People with severe mental illness, or cannot be evaluated due to cultural or psychological factors;
6. No sexual life;
7. Critical organ dysfunction, unbearable surgery;
8. Unstable angina, myocardial infarction, cerebral infarction or hemorrhage within 6 months;
9. Systemic corticosteroids or immunosuppressive medication history within 1 month;
10. Pre-existent true incontinence or severe stress urinary incontinence.

Exit criteria:

1. Confirmed as M1 during or after operation;
2. Conversion to abdominoperineal resection (APR)
3. Postoperatively confirmed as invading rectal intrinsic fascia, or T3 for anterior rectal wall;
4. Intraoperative confirmed regional lymph node fusion conglobation cannot ensure R0 resection;
5. Infiltrating major blood vessel and unresectable;
6. Intraoperative finding other diseases need simultaneous surgery;
7. Preoperative emergent severe complications, cannot carry out the study treatment;
8. Emergency surgery is needed;
9. Into this study, at any stage of the initiative exit or discontinue treatment; Prove to implement the healer violates this research plan.

Primary outcomes:
measure: Urinary function
timeFrame: 14 days
measure: Sexual function
timeFrame: 14 days
Secondary outcomes:
measure: Morbidity
timeFrame: 30 days
measure: 3-year overall survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: Mortality
timeFrame: 30 days
measure: 5-year overall survival rate
timeFrame: 60 months
measure: 5-year recurrence pattern
timeFrame: 60 months
measure: 3-year disease free survival rate
timeFrame: 36 months
measure: 5-year disease free survival rate
timeFrame: 60 months
measure: Sexual function
timeFrame: 12 months
measure: Sexual function
timeFrame: 12 months
measure: Urinary function
timeFrame: 12 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
citation: Wei B, Zheng Z, Fang J, Xiao J, Han F, Huang M, Xu Q, Wang X, Hong C, Wang G, Ju Y, Su G, Deng H, Zhang J, Li J, Chen T, Huang Y, Huang J, Liu J, Yang X, Wei H; Chinese Postoperative Urogenital Function (PUF) Research Collaboration Group. Effect of Denonvilliers' Fascia Preservation Versus Resection During Laparoscopic Total Mesorectal Excision on Postoperative Urogenital Function of Male Rectal Cancer Patients: Initial Results of Chinese PUF-01 Randomized Clinical Trial. Ann Surg. 2021 Dec 1;274(6):e473-e480. doi: 10.1097/SLA.0000000000004591.