Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery

January 26, 2019 updated by: Hongbo Wei, Third Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

172

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • The third affiliated hospital of Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preservation of Denonvilliers Fascia
Preservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients
Procedure: Preservation of Denonvilliers Fascia
In this group, patients accepte L-PANP surgery without excision of Denonvilliers Fascia
Active Comparator: Excision of Denonvilliers Fascia
Excision of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients
Procedure: Excision of Denonvilliers Fascia
In this group, patients accepte L-PANP surgery with excision of Denonvilliers Fascia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
3-year disease free survival rate
Time Frame: 36 months
36 months
Urinary function
Time Frame: 30 days
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
30 days
Sexual function
Time Frame: 30 days
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
30 days
5-year disease free survival rate
Time Frame: 60 months
60 months
Urinary function
Time Frame: 36 months
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
36 months
Sexual function
Time Frame: 36 months
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 30 days
30 days
Morbidity
Time Frame: 30 days
30 days
3-year recurrence pattern
Time Frame: 36 months
36 months
3-year overall survival rate
Time Frame: 36 months
36 months
5-year overall survival rate
Time Frame: 60 months
60 months
Morbidity
Time Frame: 36 months
36 months
Mortality
Time Frame: 36 months
36 months
5-year recurrence pattern
Time Frame: 60 months
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Actual)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 26, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED-PANP001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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