Post-operative Hernias After Radical Cystectomy

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

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

Study Overview

• Status: Unknown
• Conditions: Hernia; Evisceration; Traumatic
• Intervention / Treatment: Procedure: Cystectomy

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who undergo cystectomy for cancer or not at the CHU de Montpellier, Nîmes and the Beau Soleil clinic

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who undergo a cystectomy; Patients who undergo a cystectomy for cancer or not, since 2010 to 2020	Procedure: Cystectomy; Cystectomy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Guillaume Aujoulat, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2010
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 6, 2020
• First Posted (Actual): November 12, 2020

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Cystectomy; Parastomal hernia; Median hernia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pathological Conditions, Anatomical; Hernia; Incisional Hernia
• Other Study ID Numbers: RECHMPL20_0604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

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