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

Completed

• Conditions: Rectourethral Fistula
• Interventions: Procedure: Gracilis flap interposition for rectouretral fistula management

• Registration Number: NCT04654715
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-15
• Primary Completion: 2020-11-20
• Study Completion: 2020-11-20
• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-12-03
• Study First Posted: 2020-12-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-04
• Last Update Posted: 2021-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Localized prostate cancer treatment induced rectourethral fistula	Gracilis flap interposition for rectouretral fistula management	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).

Primary Outcome Measures

Name	Time	Method
Surgical scarring	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	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.
Urinary continence	3 months after surgery	Urinary Symptom Profile form (from 0 to 39), a higher score indicating a worse outcome.
Fecal continence	3 months after surgery	St. Marks form (from 0 to 26), a higher score indicating a worse outcome.
Lower extremity functional	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.

Trial Locations

Locations (1)

Hôpital Lyon Sud; 🇫🇷 Pierre-Bénite, France