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

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ClinicalTrials.gov Identifier: NCT02435758
Recruitment Status : Recruiting
First Posted : May 6, 2015
Last Update Posted : April 14, 2020
Sponsor:
Collaborators:
Sixth Affiliated Hospital, Sun Yat-sen University
Nanfang Hospital of Southern Medical University
Information provided by (Responsible Party):
Hongbo Wei, Third Affiliated Hospital, Sun Yat-Sen University

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.


Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: Preservation of Denonvilliers Fascia during L-PANP surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Experimental: Preservation of Denonvilliers Fascia
Preservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for male mid-low rectal cancer patients
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

No Intervention: Excision of Denonvilliers Fascia
Standard TME surgery (U-shaped excision of Denonvilliers fascia) in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for male mid-low rectal cancer patients



Primary Outcome Measures :
  1. Urinary function [ Time Frame: 14 days ]
    Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function

  2. Sexual function [ Time Frame: 14 days ]
    IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function


Secondary Outcome Measures :
  1. Morbidity [ Time Frame: 30 days ]
    incidence of postoperatvie complications

  2. 3-year overall survival rate [ Time Frame: 36 months ]
    3-year overall survival rate

  3. 3-year recurrence pattern [ Time Frame: 36 months ]
    3-year recurrence pattern

  4. Mortality [ Time Frame: 30 days ]
    incidence of postoperatvie deaths

  5. 5-year overall survival rate [ Time Frame: 60 months ]
    5-year overall survival rate

  6. 5-year recurrence pattern [ Time Frame: 60 months ]
    5-year recurrence pattern

  7. 3-year disease free survival rate [ Time Frame: 36 months ]
    3-year disease free survival rate

  8. 5-year disease free survival rate [ Time Frame: 60 months ]
    5-year disease free survival rate

  9. Sexual function [ Time Frame: 12 months ]
    International questionnaire of erectile function-5 (IIEF-5)

  10. Sexual function [ Time Frame: 12 months ]
    Ejaculation function classification

  11. Urinary function [ Time Frame: 12 months ]
    Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function



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Ages Eligible for Study:   20 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02435758


Locations
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China, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Hongbo Wei, M.D., Ph.D.    8613760660785      
Principal Investigator: Hongbo Wei, M.D.,Ph.D.         
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Sixth Affiliated Hospital, Sun Yat-sen University
Nanfang Hospital of Southern Medical University
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Responsible Party: Hongbo Wei, Assistant to the Dean, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02435758    
Other Study ID Numbers: PED-PANP01
First Posted: May 6, 2015    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases