Rectal CancerNCT02311803
Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery
A study testing Preservation of Denonvilliers Fascia and Excision of Denonvilliers Fascia in people with Rectal Cancer, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Preservation of Denonvilliers Fascia and Excision of Denonvilliers Fascia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- Feb 2015to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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;
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- ASA (American Society of Anesthesiology) score class I, II, or III;
- Written informed consent;
- Urinary and sexual function normal preoperatively
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
Hongbo Wei, M.D., Ph.D., 8613760660785
Hongbo Wei, M.D.,Ph.D.
About this study
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
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.
- Conditions
- Rectal Cancer
- Being tested
- Preservation of Denonvilliers Fascia, Excision of Denonvilliers Fascia
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preservation of Denonvilliers FasciaProcedure or surgery
In this group, patients accepte L-PANP surgery without excision of Denonvilliers Fascia
Excision of Denonvilliers FasciaProcedure or surgery
In this group, patients accepte L-PANP surgery with excision of Denonvilliers Fascia
| Study group | Role | What they receive |
|---|---|---|
| Preservation of Denonvilliers Fascia | Experimental | Preservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients Receives: Procedure: Preservation of Denonvilliers Fascia |
| Excision of Denonvilliers Fascia | Active comparator | Excision of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients Receives: Procedure: Excision of Denonvilliers Fascia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary function
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Measured: 30 days
Sexual function
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
Measured: 30 days
3-year disease free survival rate
Measured: 36 months
5-year disease free survival rate
Measured: 60 months
Urinary function
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Measured: 36 months
Sexual function
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
Measured: 36 months
Secondary outcomes (8)
Morbidity
Measured: 30 days
3-year overall survival rate
Measured: 36 months
3-year recurrence pattern
Measured: 36 months
Mortality
Measured: 30 days
Morbidity
Measured: 36 months
Mortality
Measured: 36 months
5-year overall survival rate
Measured: 60 months
5-year recurrence pattern
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2014 (estimated)
- Study startFeb 2015
- Primary completionDec 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongbo Wei, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02311803
- Sponsor's protocol ID
- PED-PANP001
- Status last verified
- Jan 2019
- First submitted
- 4 Dec 2014
- Last updated
- 29 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02311803
- Acronym / sponsor ID
- PED-PANP001
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 8 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preservation of Denonvilliers Fascia | Experimental | Procedure: Preservation of Denonvilliers FasciaPreservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients |
| Excision of Denonvilliers Fascia | Active comparator | Procedure: Excision of Denonvilliers FasciaExcision of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery for male mid-low rectal cancer patients |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preservation of Denonvilliers FasciaIn this group, patients accepte L-PANP surgery without excision of Denonvilliers Fascia | Procedure or surgery | Preservation of Denonvilliers Fascia |
| Excision of Denonvilliers FasciaIn this group, patients accepte L-PANP surgery with excision of Denonvilliers Fascia | Procedure or surgery | Excision of Denonvilliers Fascia |
Primary outcome
Urinary function
Time frame: 30 days
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Sexual function
Time frame: 30 days
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
3-year disease free survival rate
Time frame: 36 months
5-year disease free survival rate
Time frame: 60 months
Urinary function
Time frame: 36 months
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Sexual function
Time frame: 36 months
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
8 secondary outcomes
Morbidity
Time frame: 30 days
3-year overall survival rate
Time frame: 36 months
3-year recurrence pattern
Time frame: 36 months
Mortality
Time frame: 30 days
Morbidity
Time frame: 36 months
Mortality
Time frame: 36 months
5-year overall survival rate
Time frame: 60 months
5-year recurrence pattern
Time frame: 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preservation of Denonvilliers Fascia and Excision of Denonvilliers Fascia in people with Rectal Cancer, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary function (time frame: 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.