Rectal CancerNCT02435758
Multicenter Study on Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery
A study testing Preservation of Denonvilliers Fascia during L-PANP surgery 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 71 years, men only
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Preservation of Denonvilliers Fascia during L-PANP surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to 15 Jun 2023
- 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 71 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630
About this study
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.
- Conditions
- Rectal Cancer
- Being tested
- Preservation of Denonvilliers Fascia during L-PANP surgery
- 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 Fascia during L-PANP surgeryProcedure or surgery
In this group, the patients accept L-PANP surgery, as well as preservation 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 with TME for male mid-low rectal cancer patients Receives: Procedure: Preservation of Denonvilliers Fascia during L-PANP surgery |
| Excision of Denonvilliers Fascia | No intervention | 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 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: 14 days
Sexual function
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
Measured: 14 days
Secondary outcomes (11)
Morbidity
incidence of postoperatvie complications
Measured: 30 days
3-year overall survival rate
3-year overall survival rate
Measured: 36 months
3-year recurrence pattern
3-year recurrence pattern
Measured: 36 months
Mortality
incidence of postoperatvie deaths
Measured: 30 days
5-year overall survival rate
5-year overall survival rate
Measured: 60 months
5-year recurrence pattern
5-year recurrence pattern
Measured: 60 months
3-year disease free survival rate
3-year disease free survival rate
Measured: 36 months
5-year disease free survival rate
5-year disease free survival rate
Measured: 60 months
Sexual function
International questionnaire of erectile function-5 (IIEF-5)
Measured: 12 months
Sexual function
Ejaculation function classification
Measured: 12 months
Urinary function
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startApr 2015
- Primary completion6 May 2020
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University, Nanfang Hospital, Southern Medical University
- Responsible party
- Principal investigator, Hongbo Wei, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435758
- Sponsor's protocol ID
- PED-PANP01
- Status last verified
- Sep 2023
- First submitted
- 26 Apr 2015
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33234798
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study on Preservation Versus Excision of Denonvilliers Fascia in L-PANP Surgery
- ClinicalTrials.gov ID
- NCT02435758
- Acronym / sponsor ID
- PED-PANP01
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University, Nanfang Hospital, Southern Medical University
- Study start
- Apr 2015
- Primary completion
- 6 May 2020 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 6 May 2015 (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 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 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 Fascia during L-PANP surgeryPreservation of Denonvilliers Fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for male mid-low rectal cancer patients |
| Excision of Denonvilliers Fascia | No intervention | –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 |
Who may qualify
- Ages
- 20 to 71 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (20 listed)
- 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;
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 Fascia during L-PANP surgeryIn this group, the patients accept L-PANP surgery, as well as preservation of Denonvilliers Fascia | Procedure or surgery | Preservation of Denonvilliers Fascia |
Primary outcome
Urinary function
Time frame: 14 days
Urodynamic study and IPSS (International prostate symptom score) are used to assess urinary function
Sexual function
Time frame: 14 days
IIEF-5 (International questionnaire of erectile function-5) and Ejaculation function classification are used to assess sexual function
11 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
5-year overall survival rate
Time frame: 60 months
5-year recurrence pattern
Time frame: 60 months
3-year disease free survival rate
Time frame: 36 months
5-year disease free survival rate
Time frame: 60 months
Sexual function
Time frame: 12 months
Sexual function
Time frame: 12 months
Urinary function
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 33234798Wei 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 during L-PANP surgery 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 8 inclusion and 20 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: finished, as of the sponsor's last update on 21 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary function (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02435758, which also lists 1 linked publication.
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 21 Sep 2023.