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

Rectourethral Fistula Clinical Trial

— GRA-FUR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04654715
• Other study ID #: 69HCL20_0673
• Status: Completed
• Start date: October 15, 2020
• Est. completion date: November 20, 2020

Study information

• Verified date: February 2021
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 20, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Prostatic Neoplasms
• Rectourethral Fistula

Intervention

Procedure:
• Gracilis flap interposition for rectouretral fistula management
Gracilis flap interposition is a surgery for rectouretral fistula

Locations

Country	Name	City	State
France	Hôpital Lyon Sud	Pierre-Bénite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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