Multicenter Study on Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery

Rectal Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02435758
• Other study ID #: PED-PANP01
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: June 15, 2023

Study information

• Verified date: September 2023
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 262
• Est. completion date: June 15, 2023
• Est. primary completion date: May 6, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 71 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• Preservation of Denonvilliers Fascia during L-PANP surgery
In this group, the patients accept L-PANP surgery, as well as preservation of Denonvilliers Fascia

Locations

Country	Name	City	State
China	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University	Nanfang Hospital, Southern Medical University, Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary function	Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function	14 days
Primary	Sexual function	IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function	14 days
Secondary	Morbidity	incidence of postoperatvie complications	30 days
Secondary	3-year overall survival rate	3-year overall survival rate	36 months
Secondary	3-year recurrence pattern	3-year recurrence pattern	36 months
Secondary	Mortality	incidence of postoperatvie deaths	30 days
Secondary	5-year overall survival rate	5-year overall survival rate	60 months
Secondary	5-year recurrence pattern	5-year recurrence pattern	60 months
Secondary	3-year disease free survival rate	3-year disease free survival rate	36 months
Secondary	5-year disease free survival rate	5-year disease free survival rate	60 months
Secondary	Sexual function	International questionnaire of erectile function-5 (IIEF-5)	12 months
Secondary	Sexual function	Ejaculation function classification	12 months
Secondary	Urinary function	Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function	12 months