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

September 17, 2023 updated by: Hongbo Wei, Third Affiliated Hospital, Sun Yat-Sen University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
262

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Preservation of Denonvilliers Fascia
Preservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for male mid-low rectal cancer patients
Procedure: Preservation of Denonvilliers Fascia during L-PANP surgery
In this group, the patients accept L-PANP surgery, as well as preservation of Denonvilliers Fascia
No Intervention: Excision of Denonvilliers Fascia
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Urinary function
Time Frame: 14 days
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
14 days
Sexual function
Time Frame: 14 days
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
3-year disease free survival rate
Time Frame: 36 months
3-year disease free survival rate
36 months
3-year recurrence pattern
Time Frame: 36 months
3-year recurrence pattern
36 months
Morbidity
Time Frame: 30 days
incidence of postoperatvie complications
30 days
Mortality
Time Frame: 30 days
incidence of postoperatvie deaths
30 days
3-year overall survival rate
Time Frame: 36 months
3-year overall survival rate
36 months
5-year overall survival rate
Time Frame: 60 months
5-year overall survival rate
60 months
5-year disease free survival rate
Time Frame: 60 months
5-year disease free survival rate
60 months
5-year recurrence pattern
Time Frame: 60 months
5-year recurrence pattern
60 months
Sexual function
Time Frame: 12 months
International questionnaire of erectile function-5 (IIEF-5)
12 months
Sexual function
Time Frame: 12 months
Ejaculation function classification
12 months
Urinary function
Time Frame: 12 months
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Third Affiliated Hospital, Sun Yat-Sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sixth Affiliated Hospital, Sun Yat-sen University
Nanfang Hospital, Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 6, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PED-PANP01

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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