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NCT Number: NCT02435758

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

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.

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Key information

Age range

20 year–71 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Exit criteria:

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

Treatment and study plan

Preservation of Denonvilliers Fascia during L-PANP surgery

Procedure

In this group, the patients accept L-PANP surgery, as well as preservation of Denonvilliers Fascia

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Other

Collaborators

  • Nanfang Hospital, Southern Medical University
  • Sixth Affiliated Hospital, Sun Yat-sen University

Registry information

Important dates

Study start
2015
Primary completion
2020
Study completion
2023
First posted
May 6, 2015
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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