NCT04626336

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2010

Completed
10.8 years until next milestone

First Submitted

Initial submission to the registry

November 2, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 12, 2020

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

November 12, 2020

Status Verified

November 1, 2020

Enrollment Period

10.8 years

First QC Date

November 2, 2020

Last Update Submit

November 6, 2020

Conditions

Evisceration; TraumaticHernia

Keywords

Median herniaParastomal herniaCystectomy

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Patients who undergo a cystectomy

Patients who undergo a cystectomy for cancer or not, since 2010 to 2020

Procedure: Cystectomy

Interventions

CystectomyPROCEDURE

Cystectomy

Patients who undergo a cystectomy

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • having undergone a cystectomy (for cancer or not),
  • with or without reconstruction, between 01/01/2010 and 12/31/2020

You may not qualify if:

  • \- refusing to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Hernia

Interventions

Cystectomy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Urologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Guillaume Aujoulat

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 12, 2020

Study Start

January 30, 2010

Primary Completion

December 1, 2020

Study Completion

December 30, 2020

Last Updated

November 12, 2020

Record last verified: 2020-11

Locations

FR(1)