Rectourethral FistulaGRA-FURNCT04654715
Surgical and Functional Outcomes of Rectourethral Fistulas Surgery With Gracilis Flap Interposition After Localized Prostatic Cancer Treatment.
An observational study of Rectourethral Fistula, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Prostate cancer is the first cancer amongst men with more than 50000 cases per year in France. Surgical, radiation, frost, or ultrasound induced rectourethral fistula is a rare complication (<1%) of localized prostatic cancer treatment but hard to manage. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Rectourethral Fistula
- What is being tested?
- Gracilis flap interposition for rectouretral fistula management
- Type of treatment
- Surgery or procedure
- How many people
- 17 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2020to 20 Nov 2020
- Phase
- Observational
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Male patients over 18 that have been treated for a localized prostatic cancer and who were affected with a treatment-induced rectourethral fistula
Who may be able to join
- Male over 18 years old
- Treated for a localized prostatic cancer (Prostatectomy, cryotherapy, HIFU, radiotherapy)
- Affected with a treatment induced Rectourethral fistula
Who cannot join
- Rectourethral fistula caused by other pelvic diseases (gynecological or digestif cancer, inflammatory bowel disease, other urogenital issues)
- Rectourethral fistula treated by cysto-prostatectomy with urinary tract derivation
- Patient under guardianship
- Non comprehension of written or spoken French
Trial locations and contacts
1 site in 1 country.
About this study
Prostate cancer is the first cancer amongst men with more than 50000 cases per year in France. Surgical, radiation, frost, or ultrasound induced rectourethral fistula is a rare complication (<1%) of localized prostatic cancer treatment but hard to manage. Different types of treatment exist: conservatory, trans-sphinteric (York-Masson), transanal, perineal, with or without muscle flap interposition. Gracilis flap interposition for rectourethral fistula management is a promising technique but few cases are described and functional results are scarce.
The aim of this study is to present surgical and functional outcomes of rectourethral fistulas surgery with gracilis flap interposition after treatment of localized prostate cancer.
- Conditions
- Rectourethral Fistula
- Being tested
- Gracilis flap interposition for rectouretral fistula management
- Keywords
- rectourethral fistula, Gracilis flap, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gracilis flap interposition for rectouretral fistula managementProcedure or surgery
Gracilis flap interposition is a surgery for rectouretral fistula
| Study group | Role | What they receive |
|---|---|---|
| Localized prostate cancer treatment induced rectourethral fistula | Every patient over 18 years old operated for closure of a rectourethral fistula with gracilis flap interposition after localized prostatic cancer treatment (Radiotherapy, surgery, cryotherapy and HIFU). Receives: Procedure: Gracilis flap interposition for rectouretral fistula management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary continence
Urinary Symptom Profile form (from 0 to 39), a higher score indicating a worse outcome.
Measured: 3 months after surgery
Fecal continence
St. Marks form (from 0 to 26), a higher score indicating a worse outcome.
Measured: 3 months after surgery
Lower extremity functional
No validated form exist for surgical consequences after gracilis retrieval. The form used in this study is specific (Difficulty scale for walking, kneeling, crossing the legs ; limitation of movements since the operation (yes/no and which one) (From 0 to 20), a higher score indicating a worse outcome.
Measured: 3 months after surgery
Surgical scarring
The Patient and Observer Scar Assessment Scale (From 7 to 70), a higher score indicating a worse outcome.
Measured: 3 months after surgery
Global satisfaction of the surgery
Patients will give a number to measure their global satisfaction of the surgery (From 1 to 10), a higher score indicating a better outcome.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start15 Oct 2020
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectourethral FistulaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654715
- Sponsor's protocol ID
- 69HCL20_0673
- Acronym
- GRA-FUR
- Status last verified
- Feb 2021
- First submitted
- 25 Nov 2020
- Last updated
- 5 Feb 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 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical and Functional Outcomes of Rectourethral Fistulas Surgery With Gracilis Flap Interposition After Localized Prostatic Cancer Treatment.
- ClinicalTrials.gov ID
- NCT04654715
- Acronym / sponsor ID
- GRA-FUR / 69HCL20_0673
- Conditions
- Rectourethral Fistula
- Keywords
- rectourethral fistula, Gracilis flap, prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 4 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.
Prostate cancer is the first cancer amongst men with more than 50000 cases per year in France. Surgical, radiation, frost, or ultrasound induced rectourethral fistula is a rare complication (<1%) of localized prostatic cancer treatment but hard to manage. Different types of treatment exist: conservatory, trans-sphinteric (York-Masson), transanal, perineal, with or without muscle flap interposition. Gracilis flap interposition for rectourethral fistula management is a promising technique but few cases are described and functional results are scarce.
The aim of this study is to present surgical and functional outcomes of rectourethral fistulas surgery with gracilis flap interposition after treatment of localized prostate cancer.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Localized prostate cancer treatment induced rectourethral fistula | – | Procedure: Gracilis flap interposition for rectouretral fistula managementEvery patient over 18 years old operated for closure of a rectourethral fistula with gracilis flap interposition after localized prostatic cancer treatment (Radiotherapy, surgery, cryotherapy and HIFU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male patients over 18 that have been treated for a localized prostatic cancer and who were affected with a treatment-induced rectourethral fistula
Key inclusion criteria (3 listed)
- Male over 18 years old
- Treated for a localized prostatic cancer (Prostatectomy, cryotherapy, HIFU, radiotherapy)
- Affected with a treatment induced Rectourethral fistula
Key exclusion criteria (4 listed)
- Rectourethral fistula caused by other pelvic diseases (gynecological or digestif cancer, inflammatory bowel disease, other urogenital issues)
- Rectourethral fistula treated by cysto-prostatectomy with urinary tract derivation
- Patient under guardianship
- Non comprehension of written or spoken French
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 |
|---|---|---|
| Gracilis flap interposition for rectouretral fistula managementGracilis flap interposition is a surgery for rectouretral fistula | Procedure or surgery | Localized prostate cancer treatment induced rectourethral fistula |
Primary outcome
Urinary continence
Time frame: 3 months after surgery
Urinary Symptom Profile form (from 0 to 39), a higher score indicating a worse outcome.
Fecal continence
Time frame: 3 months after surgery
St. Marks form (from 0 to 26), a higher score indicating a worse outcome.
Lower extremity functional
Time frame: 3 months after surgery
No validated form exist for surgical consequences after gracilis retrieval. The form used in this study is specific (Difficulty scale for walking, kneeling, crossing the legs ; limitation of movements since the operation (yes/no and which one) (From 0 to 20), a higher score indicating a worse outcome.
Surgical scarring
Time frame: 3 months after surgery
The Patient and Observer Scar Assessment Scale (From 7 to 70), a higher score indicating a worse outcome.
Global satisfaction of the surgery
Time frame: 3 months after surgery
Patients will give a number to measure their global satisfaction of the surgery (From 1 to 10), a higher score indicating a better outcome.
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 5 Feb 2021.
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?
An observational study of Rectourethral Fistula, run by Hospices Civils de Lyon at 1 site in France.
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 3 inclusion and 4 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 5 Feb 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 France. 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 continence (time frame: 3 months after surgery). The study lists 5 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 5 Feb 2021.