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Complete Versus Partial Preservation of Denonvilliers' Fascia on Urogenital Function in Locally Advanced Rectal Cancer

Primary Purpose

Rectal Cancer, Advanced Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Complete Preservation of Denonvilliers' Fascia
Sponsored by
Sixth Affiliated Hospital, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Urogenital Function, Denonvilliers' Fascia

Eligibility Criteria

18 Years - 71 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Pathological diagnosis of rectal adenocarcinoma;
  2. Preoperative staging cT3-4 and or N+，M0 rectal cancer (AJCC- 7th);
  3. Non-anterior wall, mid-low rectal cancer from 0 to 12 cm from the anal verge measured by rigid proctoscope;
  4. R0 surgical results is expected by transabdominal or transanal TME/TSME;
  5. 18 < age (years) < 71, informed consent;
  6. Normal erection function (IIEF-5>21), ejaculation function grading as I level, FSFI > 26, normal urinary function (Bladder residual urine<100ml);
  7. Preoperative ASA grade I ~ III, no serious systemic disease;

Exclusion Criteria:

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

Sites / Locations

  • Sixth Affiliated Hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Complete Preservation of Denonvilliers Fascia

Partial Preservation of Denonvilliers Fascia

Arm Description

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

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

Outcomes

Primary Outcome Measures

Incidence of sexual dysfunction
IIEF-5(International questionnaire of erectile function-5), Ejaculation function and FSFI questionnaires are used to assess sexual function
Incidence of urinary dysfunction
IPSS(International prostate symptom score), ICIQ, bladder residual urine volume and urodynamic study are used to assess urinary function

Secondary Outcome Measures

Incidence of sexual dysfunction
IIEF-5, Ejaculation function and FSFI questionnaires are used to assess sexual function
Incidence of urinary dysfunction
IPSS, ICIQ questionnaires, bladder residual urine volume and urodynamic study are used to assess urinary function
Quality of life assessed with GIQLI questionnaires
GIQLI questionnaires are used to assess quality of life
Quality of life assessed with GIQLI questionnaires
GIQLI questionnaires are used to assess quality of life
1-year local recurrence
1-year local recurrence
1-year overall survival rate
1-year overall survival rate
Positive Circumferential Resection Margin Rate
Positive Circumferential Resection Margin Rate

Full Information

First Posted
December 11, 2020
Last Updated
April 27, 2021
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT04672603
Brief Title
Complete Versus Partial Preservation of Denonvilliers' Fascia on Urogenital Function in Locally Advanced Rectal Cancer
Official Title
Effects of Complete Preservation Versus Partial Preservation of Denonvilliers' Fascia on Postoperative Urogenital Function in Locally Advanced Non-anterior Mid-low Rectal Cancer Patients：A Multicenter，Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Advanced Cancer
Keywords
Urogenital Function, Denonvilliers' Fascia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Complete Preservation of Denonvilliers Fascia
Arm Type
Experimental
Arm Description
Complete preservation of Denonvilliers fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for mid-low rectal cancer patients.
Arm Title
Partial Preservation of Denonvilliers Fascia
Arm Type
No Intervention
Arm Description
Partial preservation of Denonvilliers fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for mid-low rectal cancer patients.
Intervention Type
Procedure
Intervention Name(s)
Complete Preservation of Denonvilliers' Fascia
Intervention Description
Patients accept L-PANP surgery with complete preservation of Denonvilliers Fascia
Primary Outcome Measure Information:
Title
Incidence of sexual dysfunction
Description
IIEF-5(International questionnaire of erectile function-5), Ejaculation function and FSFI questionnaires are used to assess sexual function
Time Frame
1 month
Title
Incidence of urinary dysfunction
Description
IPSS(International prostate symptom score), ICIQ, bladder residual urine volume and urodynamic study are used to assess urinary function
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Incidence of sexual dysfunction
Description
IIEF-5, Ejaculation function and FSFI questionnaires are used to assess sexual function
Time Frame
9 months
Title
Incidence of urinary dysfunction
Description
IPSS, ICIQ questionnaires, bladder residual urine volume and urodynamic study are used to assess urinary function
Time Frame
9 months
Title
Quality of life assessed with GIQLI questionnaires
Description
GIQLI questionnaires are used to assess quality of life
Time Frame
1month
Title
Quality of life assessed with GIQLI questionnaires
Description
GIQLI questionnaires are used to assess quality of life
Time Frame
9 months
Title
1-year local recurrence
Description
1-year local recurrence
Time Frame
1 year
Title
1-year overall survival rate
Description
1-year overall survival rate
Time Frame
1 year
Title
Positive Circumferential Resection Margin Rate
Description
Positive Circumferential Resection Margin Rate
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; 18 < 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; Exclusion Criteria: 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bing Zeng, M.D.
Phone
8613450366467
Email
zengbing3@mail.sysu.edu.cn
Facility Information:
Facility Name
Sixth Affiliated Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510655
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Zeng, M.D.
Phone
8613450366467
Email
zengbing3@mail.sysu.edu.cn

12. IPD Sharing Statement

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Complete Versus Partial Preservation of Denonvilliers' Fascia on Urogenital Function in Locally Advanced Rectal Cancer

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