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OpenTrials
Completed

NCT Number: NCT04654715

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

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.

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Key information

Conditions

Rectourethral Fistula Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Hôpital Lyon Sud

Pierre-Bénite, 69310, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gracilis flap interposition for rectouretral fistula management

Procedure

Gracilis flap interposition is a surgery for rectouretral fistula

Primary outcomes

  1. Urinary continence

    Time frame: 3 months after surgery

    Urinary Symptom Profile form (from 0 to 39), a higher score indicating a worse outcome.

  2. Fecal continence

    Time frame: 3 months after surgery

    St. Marks form (from 0 to 26), a higher score indicating a worse outcome.

  3. Lower extremity functional

    Time frame: 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.

  4. Surgical scarring

    Time frame: 3 months after surgery

    The Patient and Observer Scar Assessment Scale (From 7 to 70), a higher score indicating a worse outcome.

  5. Global satisfaction of the surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: GRA-FUR

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 4, 2020
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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