Surgical and Functional Outcomes of Rectourethral Fistulas Surgery With Gracilis Flap Interposition After Localized Prostatic Cancer Treatment. (GRA-FUR)

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 Overview

• Status: Completed
• Conditions: Rectourethral Fistula
• Intervention / Treatment: Procedure: Gracilis flap interposition for rectouretral fistula management

• Study Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France, 69310
    • Hopital Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).	Procedure: Gracilis flap interposition for rectouretral fistula management; Gracilis flap interposition is a surgery for rectouretral fistula

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): November 20, 2020
• Study Completion (Actual): November 20, 2020

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 4, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: prostate cancer; rectourethral fistula; Gracilis flap
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Pathological Conditions, Anatomical; Prostatic Neoplasms; Fistula
• Other Study ID Numbers: 69HCL20_0673

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No