NCT02435758

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 6, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2020

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

5.1 years

First QC Date

April 26, 2015

Last Update Submit

September 17, 2023

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (2)

  • Urinary function

    Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function

    14 days

  • Sexual function

    IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function

    14 days

Secondary Outcomes (11)

  • Morbidity

    30 days

  • 3-year overall survival rate

    36 months

  • 3-year recurrence pattern

    36 months

  • Mortality

    30 days

  • 5-year overall survival rate

    60 months

  • +6 more secondary outcomes

Study Arms (2)

Preservation of Denonvilliers Fascia

EXPERIMENTAL

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

Excision of Denonvilliers Fascia

NO INTERVENTION

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

Interventions

Preservation of Denonvilliers Fascia during L-PANP surgeryPROCEDURE

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

Preservation of Denonvilliers Fascia

Eligibility Criteria

Age20 Years - 71 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

Related Publications (1)

  • 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.

    PMID: 33234798DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant to the Dean

Study Record Dates

First Submitted

April 26, 2015

First Posted

May 6, 2015

Study Start

April 1, 2015

Primary Completion

May 6, 2020

Study Completion

June 15, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

CN(1)