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Surgical and Functional Outcomes of Rectourethral Fistulas Surgery With Gracilis Flap Interposition After Localized Prostatic Cancer Treatment.

Surgical and Functional Outcomes of Rectourethral Fistulas Surgery With Gracilis Flap Interposition After Localized Prostatic Cancer Treatment.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04654715
Acronym
GRA-FUR
Enrollment
17
Registered
2020-12-04
Start date
2020-10-15
Completion date
2020-11-20
Last updated
2021-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectourethral Fistula

Keywords

rectourethral fistula, Gracilis flap, prostate cancer

Brief 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. 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.

Interventions

PROCEDUREGracilis flap interposition for rectouretral fistula management

Gracilis flap interposition is a surgery for rectouretral fistula

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Male over 18 years old * Treated for a localized prostatic cancer (Prostatectomy, cryotherapy, HIFU, radiotherapy) * Affected with a treatment induced Rectourethral fistula

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Urinary continence3 months after surgeryUrinary Symptom Profile form (from 0 to 39), a higher score indicating a worse outcome.
Fecal continence3 months after surgerySt. Marks form (from 0 to 26), a higher score indicating a worse outcome.
Global satisfaction of the surgery3 months after surgeryPatients will give a number to measure their global satisfaction of the surgery (From 1 to 10), a higher score indicating a better outcome.
Lower extremity functional3 months after surgeryNo 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 scarring3 months after surgeryThe Patient and Observer Scar Assessment Scale (From 7 to 70), a higher score indicating a worse outcome.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026