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NCT04626336 Clinical Trial

Post-operative Hernias After Radical Cystectomy

Hernia Clinical Trial

Official title:
Post-operative Hernias After Radical Cystectomy : Incidence and Risks Factors

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04626336
Other study ID # RECHMPL20_0604
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 30, 2010
Est. completion date December 30, 2020

Study information
Verified date November 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Post-operative hernias after cystectomy are frequent (our review of the literature with meta-analysis found an incidence of evisceration at 5%, median eventrations at 8% and peristomal hernias at 14%). These represent a non-negligible and partially morbidity. avoidable, subject to proper assessment of personal and surgical risk factors

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 800
Est. completion date December 30, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years to 90 Years
Eligibility Inclusion criteria: - having undergone a cystectomy (for cancer or not), - with or without reconstruction, between 01/01/2010 and 12/31/2020 Exclusion criteria: - refusing to participate

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Cystectomy
Cystectomy

Locations
Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Type of post-operative hernias Type of post-operative hernias : evisceration, median hernia, parastomal hernia 1 day
Primary Define risk factors Type of risks factors Define risk factors: sex, BMI, diabetes, ASA, duration surgery, delay, postoperative biology 1 day
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