Bladder CancerNCT03822234
A Clinical Trial of Extraperitonealization for Prevention of Parastomal Hernia After Ileal Conduit
A study testing Modified ileal conduit in people with Bladder Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
Many complications may occur after ileal conduit, with the incidence increasing with time after surgery. Nearly half of the complications are related to stoma and ureteroileal anastomosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Modified ileal conduit
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2019to 11 Mar 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old, gender not limited, life expectancy is greater than or equal to 24 months；
- ECOG score of patients: 0-1；
- Volunteer to participate in this study and sign the informed consent；
- T2-T4a, N0-x,M0 invasive bladder cancer; High risk non-muscular invasive bladder cancer T1G3(high grade) tumor; Tis in which BCG therapy failed; Recurrent non-invasive bladder cancer; TUR and bladder perfusion were used for treatment of uncontrolled extensive papillary lesions and bladder non-urothelial carcinoma;
- Major organ functions, such as liver, kidney, bone marrow, heart and other important organs, were not significantly abnormal: AST, ALT≤2.5 upper limit of normal value (ULN); Total bilirubin (TBIL)≤1.5 ULN; Albumin (ALB)≥25g/L; Serum creatinine (CRE)≤1.5 ULN; Leukocytes≥3.5*109/L, neutrophils≥1.5*109/L, hemoglobin≥90g/L, platelets≥80*109/L; Left ventricular ejection fraction (LVEF) ≥50%; Electrocardiogram showed no obvious abnormality or no clinical significance.
Who cannot join
- A history of major middle and lower abdominal surgery;
- Obese patients （BMI≥40kg/m2）;
- Failure to receive regular follow-up review as required;
- Severe cardiovascular disease;
- History of immunodeficiency and organ transplantation；
- History of severe central nervous system disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multicenter Randomized Controlled Clinical Trial of Extraperitonealization for Prevention of Parastomal Hernia After Ileal Conduit
Many complications may occur after ileal conduit, with the incidence increasing with time after surgery. Nearly half of the complications are related to stoma and ureteroileal anastomosis. The investigators believe that the surgical technique is responsible for these complications, and therefore have devised a modified technique for creating the ileal conduit that should help prevent these complications after surgery. The investigators' retrospective study shows that modified surgical technique for ileal conduit urinary diversion appears to be effective for reducing early and late complications related to the stoma. Thus the investigators would like to perform a prospective multicenter randomized controlled clinical study to prove the investigators' results.
The investigators plan to enroll 104 patients, and randomizedly divide the participants into two groups, with one group 52 patients undergoing conventional ileal conduit, another group 52 patients undergoing modified ileal conduit.
Read the detailed description
The ileal conduit (Bricker) has been used for urinary diversion for more than half a century. Widely accepted to be a simple and safe form of urinary diversion, it remains one of the most commonly used techniques for urinary diversion after radical cystectomy for bladder cancer. However, many complications may occur after ileal conduit, with the incidence increasing with time after surgery. Interestingly, nearly half of the complications are related to stoma and ureteroileal anastomosis. Among the complications, parastomal hernia is the most common. Female gender, low preoperative serum albumin level, high BMI or severe obesity, and prior laparotomy have been shown to be risk factors for parastomal hernia. But the mechanisms by which these variables lead to stoma related complications have not yet been fully elucidated. The investigators believe that the surgical technique is responsible for these complications, and therefore have devised a modified technique for creating the ileal conduit that should help prevent these complications after surgery. The investigators' retrospective study shows that modified surgical technique for ileal conduit urinary diversion appears to be effective for reducing early and late complications related to the stoma. Thus the investigators would like to perform a prospective multicenter randomized controlled clinical study to prove the investigators' results.
The investigators plan to enroll 104 patients, and randomizedly divide the participants into two groups, with one group 52 patients undergoing conventional ileal conduit, another group 52 patients undergoing modified ileal conduit.
- Conditions
- Bladder Cancer
- Being tested
- Modified ileal conduit
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified ileal conduitProcedure or surgery
Modified ileal conduit (Extraperitonealization)
| Study group | Role | What they receive |
|---|---|---|
| Modified ileal conduit | Experimental | With our modified ileal conduit technique Receives: Procedure: Modified ileal conduit |
| Conventional ileal conduit | No intervention | Conventional ileal conduit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of parastomal hernia in 2 years
Incidence of parastomal hernia in 2 years
Measured: 2 years
Secondary outcomes (5)
Incidence of stomal retraction in 2 years
Incidence of stomal retraction in 2 years
Measured: 2 years
Incidence of stomal stenosis in 2 years
Incidence of stomal stenosis in 2 years
Measured: 2 years
Incidence of stomal prolapse in 2 years
Incidence of stomal prolapse in 2 years
Measured: 2 years
Overall Survival
Overall Survival
Measured: up to 2 years. From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 24 months
Disease-Free Survival
Disease-Free Survival
Measured: up to 2 years. From date of randomization until the date of first documented progression or recurrence or date of death from any cause, whichever came first, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start15 Jan 2019
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHOU FANGJIAN, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03822234
- Sponsor's protocol ID
- B2018-104-01
- Status last verified
- Apr 2024
- First submitted
- 23 Jan 2019
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Randomized Controlled Clinical Trial of Extraperitonealization for Prevention of Parastomal Hernia After Ileal Conduit
- ClinicalTrials.gov ID
- NCT03822234
- Acronym / sponsor ID
- B2018-104-01
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 30 Jan 2019 (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.
Many complications may occur after ileal conduit, with the incidence increasing with time after surgery. Nearly half of the complications are related to stoma and ureteroileal anastomosis. The investigators believe that the surgical technique is responsible for these complications, and therefore have devised a modified technique for creating the ileal conduit that should help prevent these complications after surgery. The investigators' retrospective study shows that modified surgical technique for ileal conduit urinary diversion appears to be effective for reducing early and late complications related to the stoma. Thus the investigators would like to perform a prospective multicenter randomized controlled clinical study to prove the investigators' results.
The investigators plan to enroll 104 patients, and randomizedly divide the participants into two groups, with one group 52 patients undergoing conventional ileal conduit, another group 52 patients undergoing modified ileal conduit.
Detailed description
The ileal conduit (Bricker) has been used for urinary diversion for more than half a century. Widely accepted to be a simple and safe form of urinary diversion, it remains one of the most commonly used techniques for urinary diversion after radical cystectomy for bladder cancer. However, many complications may occur after ileal conduit, with the incidence increasing with time after surgery. Interestingly, nearly half of the complications are related to stoma and ureteroileal anastomosis. Among the complications, parastomal hernia is the most common. Female gender, low preoperative serum albumin level, high BMI or severe obesity, and prior laparotomy have been shown to be risk factors for parastomal hernia. But the mechanisms by which these variables lead to stoma related complications have not yet been fully elucidated. The investigators believe that the surgical technique is responsible for these complications, and therefore have devised a modified technique for creating the ileal conduit that should help prevent these complications after surgery. The investigators' retrospective study shows that modified surgical technique for ileal conduit urinary diversion appears to be effective for reducing early and late complications related to the stoma. Thus the investigators would like to perform a prospective multicenter randomized controlled clinical study to prove the investigators' results.
The investigators plan to enroll 104 patients, and randomizedly divide the participants into two groups, with one group 52 patients undergoing conventional ileal conduit, another group 52 patients undergoing modified ileal conduit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified ileal conduit | Experimental | Procedure: Modified ileal conduitWith our modified ileal conduit technique |
| Conventional ileal conduit | No intervention | –Conventional ileal conduit |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 years old, gender not limited, life expectancy is greater than or equal to 24 months；
- ECOG score of patients: 0-1；
- Volunteer to participate in this study and sign the informed consent；
- T2-T4a, N0-x,M0 invasive bladder cancer; High risk non-muscular invasive bladder cancer T1G3(high grade) tumor; Tis in which BCG therapy failed; Recurrent non-invasive bladder cancer; TUR and bladder perfusion were used for treatment of uncontrolled extensive papillary lesions and bladder non-urothelial carcinoma;
- Major organ functions, such as liver, kidney, bone marrow, heart and other important organs, were not significantly abnormal: AST, ALT≤2.5 upper limit of normal value (ULN); Total bilirubin (TBIL)≤1.5 ULN; Albumin (ALB)≥25g/L; Serum creatinine (CRE)≤1.5 ULN; Leukocytes≥3.5*109/L, neutrophils≥1.5*109/L, hemoglobin≥90g/L, platelets≥80*109/L; Left ventricular ejection fraction (LVEF) ≥50%; Electrocardiogram showed no obvious abnormality or no clinical significance.
Key exclusion criteria (6 listed)
- A history of major middle and lower abdominal surgery;
- Obese patients （BMI≥40kg/m2）;
- Failure to receive regular follow-up review as required;
- Severe cardiovascular disease;
- History of immunodeficiency and organ transplantation；
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 |
|---|---|---|
| Modified ileal conduitModified ileal conduit (Extraperitonealization) | Procedure or surgery | Modified ileal conduit |
Primary outcome
Incidence of parastomal hernia in 2 years
Time frame: 2 years
Incidence of parastomal hernia in 2 years
5 secondary outcomes
Incidence of stomal retraction in 2 years
Time frame: 2 years
Incidence of stomal stenosis in 2 years
Time frame: 2 years
Incidence of stomal prolapse in 2 years
Time frame: 2 years
Overall Survival
Time frame: up to 2 years. From date of randomization until the date of first documented date of death from any cause, whichever came first, assessed up to 24 months
Disease-Free Survival
Time frame: up to 2 years. From date of randomization until the date of first documented progression or recurrence or date of death from any cause, whichever came first, assessed up to 24 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 18 Apr 2024.
- Individual participant dataSharing planned: No
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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 Modified ileal conduit in people with Bladder Cancer, run by 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 5 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: finished, as of the sponsor's last update on 18 Apr 2024. 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?
Incidence of parastomal hernia in 2 years (time frame: 2 years). 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 18 Apr 2024.