NCT04672603

Brief Summary

Total mesorectal resection (TME) is the standard surgical method for locally advanced rectal cancer, which significantly reduces the local recurrence rate. However, the incidence of urogenital dysfunction is higher. Studies found that Denonvilliers' Fascia contains autonomic nerves that may regulate urogenital function, while traditional TME surgery resects part of it. Recent Studies found that complete preservation of Denonvilliers' Fascia could improve urogenital in selected patients with rectal cancer. Locally advanced patient (T3-4 and/or N+, M0) accounts for a high proportion of mid-low rectal cancer. However, whether these patients can benefit from it has not fully been demonstrated. This project conducts a multi-center randomized controlled study to evaluate the effects of complete preservation and partial preservation of Denonvilliers' Fascia on postoperative urogenital function of locally advanced non-anterior mid-low rectal cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 8, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

2.1 years

First QC Date

December 11, 2020

Last Update Submit

April 27, 2021

Conditions

Rectal CancerAdvanced Cancer

Keywords

Urogenital FunctionDenonvilliers' Fascia

Outcome Measures

Primary Outcomes (2)

  • Incidence of sexual dysfunction

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

    1 month

  • Incidence of urinary dysfunction

    IPSS(International prostate symptom score), ICIQ, bladder residual urine volume and urodynamic study are used to assess urinary function

    1 month

Secondary Outcomes (7)

  • Incidence of sexual dysfunction

    9 months

  • Incidence of urinary dysfunction

    9 months

  • Quality of life assessed with GIQLI questionnaires

    1month

  • Quality of life assessed with GIQLI questionnaires

    9 months

  • 1-year local recurrence

    1 year

  • +2 more secondary outcomes

Study Arms (2)

Complete Preservation of Denonvilliers Fascia

EXPERIMENTAL

Complete preservation of Denonvilliers fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for mid-low rectal cancer patients.

Procedure: Complete Preservation of Denonvilliers' Fascia

Partial Preservation of Denonvilliers Fascia

NO INTERVENTION

Partial preservation of Denonvilliers fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for mid-low rectal cancer patients.

Interventions

Complete Preservation of Denonvilliers' FasciaPROCEDURE

Patients accept L-PANP surgery with complete preservation of Denonvilliers Fascia

Complete Preservation of Denonvilliers Fascia

Eligibility Criteria

Age18 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathological diagnosis of rectal adenocarcinoma;
  • Preoperative staging cT3-4 and or N+，M0 rectal cancer (AJCC- 7th);
  • Non-anterior wall, mid-low rectal cancer from 0 to 12 cm from the anal verge measured by rigid proctoscope;
  • R0 surgical results is expected by transabdominal or transanal TME/TSME;
  • \< age (years) \< 71, informed consent;
  • Normal erection function (IIEF-5\>21), ejaculation function grading as I level, FSFI \> 26, normal urinary function (Bladder residual urine\<100ml);
  • Preoperative ASA grade I \~ III, no serious systemic disease;

You may not qualify if:

  • Preoperatively confirmed peritoneum or distant metastasis;
  • Intraoperative confirmed invasion of surrounding tissues or organs, cannot be R0 resected;
  • With other malignant diseases;
  • With acute ileus, perforation or hemorrhage,need emergency surgery;
  • Critical organs dysfunction, unable to tolerate laparoscopic surgery;
  • With severe mental illness, cannot be evaluated;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Bing Zeng, M.D.

CONTACT

8613450366467zengbing3@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 17, 2020

Study Start

April 8, 2021

Primary Completion

May 1, 2023

Study Completion

May 1, 2025

Last Updated

April 29, 2021

Record last verified: 2021-04

Locations

CN(1)