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Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery

Primary Purpose

Rectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Preservation of Denonvilliers Fascia
Excision of Denonvilliers Fascia
Sponsored by
Third 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

Eligibility Criteria

20 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age from over 20 to under 60 years;
  2. Primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy;
  3. Mid-low rectal cancer (distance from anal edge≤12cm);
  4. cT1-3, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition;
  5. Expected curative resection through L-PANP;
  6. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale;
  7. ASA (American Society of Anesthesiology) score class I, II, or III;
  8. Written informed consent;
  9. Urinary and sexual function normal preoperatively

Exclusion Criteria:

  1. Severe mental disorder;
  2. History of previous pelvic surgery;
  3. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging;
  4. History of other malignant disease within past five years;
  5. History of unstable angina or myocardial infarction within past six months;
  6. History of cerebrovascular accident within past six months;
  7. History of continuous systematic administration of corticosteroids within one month;
  8. Contraindication of heart, brain, lung, etc dysfunction;
  9. Requirement of simultaneous surgery for other disease;
  10. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer;
  11. Rectal cancer invades surrounding tissues;
  12. Existence of genuine incontinence or severe stress incontinence preoperatively

Sites / Locations

  • The Third Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Preservation of Denonvilliers Fascia

Excision of Denonvilliers Fascia

Arm Description

Preservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients

Excision of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients

Outcomes

Primary Outcome Measures

Urinary function
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Sexual function
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
3-year disease free survival rate
5-year disease free survival rate
Urinary function
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Sexual function
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function

Secondary Outcome Measures

Morbidity
3-year overall survival rate
3-year recurrence pattern
Mortality
Morbidity
Mortality
5-year overall survival rate
5-year recurrence pattern

Full Information

First Posted
December 4, 2014
Last Updated
January 26, 2019
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT02311803
Brief Title
Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery
Official Title
Preservation Versus Excision of Denonvilliers Fascia in Laparoscopic Pelvic Autonomic Nerve Preserving Surgery for Male Mid-low Rectal Cancer Patients: a Randomized Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
April 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preservation of Denonvilliers Fascia
Arm Type
Experimental
Arm Description
Preservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients
Arm Title
Excision of Denonvilliers Fascia
Arm Type
Active Comparator
Arm Description
Excision of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients
Intervention Type
Procedure
Intervention Name(s)
Preservation of Denonvilliers Fascia
Intervention Description
In this group, patients accepte L-PANP surgery without excision of Denonvilliers Fascia
Intervention Type
Procedure
Intervention Name(s)
Excision of Denonvilliers Fascia
Intervention Description
In this group, patients accepte L-PANP surgery with excision of Denonvilliers Fascia
Primary Outcome Measure Information:
Title
Urinary function
Description
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Time Frame
30 days
Title
Sexual function
Description
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
Time Frame
30 days
Title
3-year disease free survival rate
Time Frame
36 months
Title
5-year disease free survival rate
Time Frame
60 months
Title
Urinary function
Description
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Time Frame
36 months
Title
Sexual function
Description
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Morbidity
Time Frame
30 days
Title
3-year overall survival rate
Time Frame
36 months
Title
3-year recurrence pattern
Time Frame
36 months
Title
Mortality
Time Frame
30 days
Title
Morbidity
Time Frame
36 months
Title
Mortality
Time Frame
36 months
Title
5-year overall survival rate
Time Frame
60 months
Title
5-year recurrence pattern
Time Frame
60 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age from over 20 to under 60 years; Primary rectal adenocarcinoma confirmed pathologically by endoscopic biopsy; Mid-low rectal cancer (distance from anal edge≤12cm); cT1-3, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition; Expected curative resection through L-PANP; Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale; ASA (American Society of Anesthesiology) score class I, II, or III; Written informed consent; Urinary and sexual function normal preoperatively Exclusion Criteria: Severe mental disorder; History of previous pelvic surgery; Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging; History of other malignant disease within past five years; History of unstable angina or myocardial infarction within past six months; History of cerebrovascular accident within past six months; History of continuous systematic administration of corticosteroids within one month; Contraindication of heart, brain, lung, etc dysfunction; Requirement of simultaneous surgery for other disease; Emergency surgery due to complication (bleeding, obstruction or perforation) caused by rectal cancer; Rectal cancer invades surrounding tissues; Existence of genuine incontinence or severe stress incontinence preoperatively
Facility Information:
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongbo Wei, M.D., Ph.D.
Phone
8613760660785
First Name & Middle Initial & Last Name & Degree
Hongbo Wei, M.D.,Ph.D.

12. IPD Sharing Statement

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Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery

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