Rectal CancerNCT04672603
Complete Versus Partial Preservation of Denonvilliers' Fascia on Urogenital Function in Locally Advanced Rectal Cancer
A study testing Complete Preservation of Denonvilliers' Fascia in people with Rectal Cancer and Advanced Cancer, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Total mesorectal resection (TME) is the standard surgical method for locally advanced rectal cancer, which significantly reduces the local recurrence rate. However, the incidence of urogenital dysfunction is higher. Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Rectal Cancer, Advanced Cancer
- What is being tested?
- Complete Preservation of Denonvilliers' Fascia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2021to 1 May 2025
- 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 18 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathological diagnosis of rectal adenocarcinoma;
- Preoperative staging cT3-4 and or N+，M0 rectal cancer (AJCC- 7th);
- Non-anterior wall, mid-low rectal cancer from 0 to 12 cm from the anal verge measured by rigid proctoscope;
- R0 surgical results is expected by transabdominal or transanal TME/TSME;
- 18 < age (years) < 71, informed consent;
- Normal erection function (IIEF-5>21), ejaculation function grading as I level, FSFI > 26, normal urinary function (Bladder residual urine<100ml);
- Preoperative ASA grade I ~ III, no serious systemic disease;
Who cannot join
- Preoperatively confirmed peritoneum or distant metastasis;
- Intraoperative confirmed invasion of surrounding tissues or organs, cannot be R0 resected;
- With other malignant diseases;
- With acute ileus, perforation or hemorrhage,need emergency surgery;
- Critical organs dysfunction, unable to tolerate laparoscopic surgery;
- With severe mental illness, cannot be evaluated;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510655
Bing Zeng, M.D., 8613450366467, zengbing3@mail.sysu.edu.cn
About this study
Official title: Effects of Complete Preservation Versus Partial Preservation of Denonvilliers' Fascia on Postoperative Urogenital Function in Locally Advanced Non-anterior Mid-low Rectal Cancer Patients：A Multicenter，Randomized Study
Total mesorectal resection (TME) is the standard surgical method for locally advanced rectal cancer, which significantly reduces the local recurrence rate. However, the incidence of urogenital dysfunction is higher. Studies found that Denonvilliers' Fascia contains autonomic nerves that may regulate urogenital function, while traditional TME surgery resects part of it. Recent Studies found that complete preservation of Denonvilliers' Fascia could improve urogenital in selected patients with rectal cancer. Locally advanced patient (T3-4 and/or N+, M0) accounts for a high proportion of mid-low rectal cancer. However, whether these patients can benefit from it has not fully been demonstrated. This project conducts a multi-center randomized controlled study to evaluate the effects of complete preservation and partial preservation of Denonvilliers' Fascia on postoperative urogenital function of locally advanced non-anterior mid-low rectal cancer.
- Conditions
- Rectal Cancer, Advanced Cancer
- Being tested
- Complete Preservation of Denonvilliers' Fascia
- Keywords
- Urogenital Function, 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.
Complete Preservation of Denonvilliers' FasciaProcedure or surgery
Patients accept L-PANP surgery with complete preservation of Denonvilliers Fascia
| Study group | Role | What they receive |
|---|---|---|
| Complete Preservation of Denonvilliers Fascia | Experimental | Complete preservation of Denonvilliers fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for mid-low rectal cancer patients. Receives: Procedure: Complete Preservation of Denonvilliers' Fascia |
| Partial Preservation of Denonvilliers Fascia | No intervention | Partial preservation of Denonvilliers fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for mid-low rectal cancer patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sexual dysfunction
IIEF-5(International questionnaire of erectile function-5), Ejaculation function and FSFI questionnaires are used to assess sexual function
Measured: 1 month
Incidence of urinary dysfunction
IPSS(International prostate symptom score), ICIQ, bladder residual urine volume and urodynamic study are used to assess urinary function
Measured: 1 month
Secondary outcomes (7)
Incidence of sexual dysfunction
IIEF-5, Ejaculation function and FSFI questionnaires are used to assess sexual function
Measured: 9 months
Incidence of urinary dysfunction
IPSS, ICIQ questionnaires, bladder residual urine volume and urodynamic study are used to assess urinary function
Measured: 9 months
Quality of life assessed with GIQLI questionnaires
GIQLI questionnaires are used to assess quality of life
Measured: 1month
Quality of life assessed with GIQLI questionnaires
GIQLI questionnaires are used to assess quality of life
Measured: 9 months
1-year local recurrence
1-year local recurrence
Measured: 1 year
1-year overall survival rate
1-year overall survival rate
Measured: 1 year
Positive Circumferential Resection Margin Rate
Positive Circumferential Resection Margin Rate
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start8 Apr 2021
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2025 (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.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672603
- Sponsor's protocol ID
- UGFS-01
- Status last verified
- Apr 2021
- First submitted
- 11 Dec 2020
- Last updated
- 29 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Complete Preservation Versus Partial Preservation of Denonvilliers' Fascia on Postoperative Urogenital Function in Locally Advanced Non-anterior Mid-low Rectal Cancer Patients：A Multicenter，Randomized Study
- ClinicalTrials.gov ID
- NCT04672603
- Acronym / sponsor ID
- UGFS-01
- Conditions
- Rectal Cancer, Advanced Cancer
- Keywords
- Urogenital Function, Denonvilliers' Fascia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 17 Dec 2020 (actual)
- 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.
Total mesorectal resection (TME) is the standard surgical method for locally advanced rectal cancer, which significantly reduces the local recurrence rate. However, the incidence of urogenital dysfunction is higher. Studies found that Denonvilliers' Fascia contains autonomic nerves that may regulate urogenital function, while traditional TME surgery resects part of it. Recent Studies found that complete preservation of Denonvilliers' Fascia could improve urogenital in selected patients with rectal cancer. Locally advanced patient (T3-4 and/or N+, M0) accounts for a high proportion of mid-low rectal cancer. However, whether these patients can benefit from it has not fully been demonstrated. This project conducts a multi-center randomized controlled study to evaluate the effects of complete preservation and partial preservation of Denonvilliers' Fascia on postoperative urogenital function of locally advanced non-anterior mid-low rectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complete Preservation of Denonvilliers Fascia | Experimental | Procedure: Complete Preservation of Denonvilliers' FasciaComplete preservation of Denonvilliers fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for mid-low rectal cancer patients. |
| Partial Preservation of Denonvilliers Fascia | No intervention | –Partial preservation of Denonvilliers fascia in Laparoscopy-assisted pelvic autonomic nerve preservation surgery with TME for mid-low rectal cancer patients. |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Pathological diagnosis of rectal adenocarcinoma;
- Preoperative staging cT3-4 and or N+，M0 rectal cancer (AJCC- 7th);
- Non-anterior wall, mid-low rectal cancer from 0 to 12 cm from the anal verge measured by rigid proctoscope;
- R0 surgical results is expected by transabdominal or transanal TME/TSME;
- 18 < age (years) < 71, informed consent;
Key exclusion criteria (6 listed)
- Preoperatively confirmed peritoneum or distant metastasis;
- Intraoperative confirmed invasion of surrounding tissues or organs, cannot be R0 resected;
- With other malignant diseases;
- With acute ileus, perforation or hemorrhage,need emergency surgery;
- Critical organs dysfunction, unable to tolerate laparoscopic surgery;
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 |
|---|---|---|
| Complete Preservation of Denonvilliers' FasciaPatients accept L-PANP surgery with complete preservation of Denonvilliers Fascia | Procedure or surgery | Complete Preservation of Denonvilliers Fascia |
Primary outcome
Incidence of sexual dysfunction
Time frame: 1 month
IIEF-5(International questionnaire of erectile function-5), Ejaculation function and FSFI questionnaires are used to assess sexual function
Incidence of urinary dysfunction
Time frame: 1 month
IPSS(International prostate symptom score), ICIQ, bladder residual urine volume and urodynamic study are used to assess urinary function
7 secondary outcomes
Incidence of sexual dysfunction
Time frame: 9 months
Incidence of urinary dysfunction
Time frame: 9 months
Quality of life assessed with GIQLI questionnaires
Time frame: 1month
Quality of life assessed with GIQLI questionnaires
Time frame: 9 months
1-year local recurrence
Time frame: 1 year
1-year overall survival rate
Time frame: 1 year
Positive Circumferential Resection Margin Rate
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
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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 Complete Preservation of Denonvilliers' Fascia in people with Rectal Cancer and Advanced Cancer, run by Sixth 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 7 inclusion and 6 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 Apr 2021. 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?
Contact Bing Zeng, M.D. (8613450366467, zengbing3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of sexual dysfunction (time frame: 1 month). 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?
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 Apr 2021.