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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rectourethral Fistula

Intervention / Treatment
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* Procedure: Gracilis flap interposition for rectouretral fistula management


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Localized prostate cancer treatment induced rectourethral fistula<br>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). | Procedure: Gracilis flap interposition for rectouretral fistula management<br>* Gracilis flap interposition is a surgery for rectouretral fistula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary continence | Urinary Symptom Profile form (from 0 to 39), a higher score indicating a worse outcome. | 3 months after surgery | 
| Fecal continence | St. Marks form (from 0 to 26), a higher score indicating a worse outcome. | 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. | 3 months after surgery | 
| Surgical scarring | The Patient and Observer Scar Assessment Scale (From 7 to 70), a higher score indicating a worse outcome. | 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. | 3 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rectourethral fistula, Gracilis flap, prostate cancer