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

Primary Purpose

Rectal Cancer

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Preservation of Denonvilliers Fascia during L-PANP surgery
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 - 71 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Exit criteria:

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

Sites / Locations

  • The Third Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Preservation of Denonvilliers Fascia

Excision of Denonvilliers Fascia

Arm Description

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

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

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

Secondary Outcome Measures

Morbidity
incidence of postoperatvie complications
3-year overall survival rate
3-year overall survival rate
3-year recurrence pattern
3-year recurrence pattern
Mortality
incidence of postoperatvie deaths
5-year overall survival rate
5-year overall survival rate
5-year recurrence pattern
5-year recurrence pattern
3-year disease free survival rate
3-year disease free survival rate
5-year disease free survival rate
5-year disease free survival rate
Sexual function
International questionnaire of erectile function-5 (IIEF-5)
Sexual function
Ejaculation function classification
Urinary function
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function

Full Information

First Posted
April 26, 2015
Last Updated
September 17, 2023
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University, Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02435758
Brief Title
Multicenter Study on Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
May 6, 2020 (Actual)
Study Completion Date
June 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University, Nanfang Hospital, Southern Medical University

4. Oversight

Data Monitoring Committee
Yes

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 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.

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
262 (Actual)

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 with TME for male mid-low rectal cancer patients
Arm Title
Excision of Denonvilliers Fascia
Arm Type
No Intervention
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Preservation of Denonvilliers Fascia during L-PANP surgery
Intervention Description
In this group, the patients accept L-PANP surgery, as well as preservation 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
14 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
14 days
Secondary Outcome Measure Information:
Title
Morbidity
Description
incidence of postoperatvie complications
Time Frame
30 days
Title
3-year overall survival rate
Description
3-year overall survival rate
Time Frame
36 months
Title
3-year recurrence pattern
Description
3-year recurrence pattern
Time Frame
36 months
Title
Mortality
Description
incidence of postoperatvie deaths
Time Frame
30 days
Title
5-year overall survival rate
Description
5-year overall survival rate
Time Frame
60 months
Title
5-year recurrence pattern
Description
5-year recurrence pattern
Time Frame
60 months
Title
3-year disease free survival rate
Description
3-year disease free survival rate
Time Frame
36 months
Title
5-year disease free survival rate
Description
5-year disease free survival rate
Time Frame
60 months
Title
Sexual function
Description
International questionnaire of erectile function-5 (IIEF-5)
Time Frame
12 months
Title
Sexual function
Description
Ejaculation function classification
Time Frame
12 months
Title
Urinary function
Description
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33234798
Citation
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.
Results Reference
derived

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

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