Evisceration; TraumaticNCT04626336
Post-operative Hernias After Radical Cystectomy
An observational study of Evisceration; Traumatic and Hernia, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Evisceration; Traumatic, Hernia
- What is being tested?
- Cystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2010to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who undergo cystectomy for cancer or not at the CHU de Montpellier, Nîmes and the Beau Soleil clinic
Who may be able to join
- having undergone a cystectomy (for cancer or not),
- with or without reconstruction, between 01/01/2010 and 12/31/2020
Who cannot join
- refusing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Evisceration; Traumatic, Hernia
- Being tested
- Cystectomy
- Keywords
- Median hernia, Parastomal hernia, Cystectomy
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CystectomyProcedure or surgery
Cystectomy
| Study group | Role | What they receive |
|---|---|---|
| Patients who undergo a cystectomy | Patients who undergo a cystectomy for cancer or not, since 2010 to 2020 Receives: Procedure: Cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of post-operative hernias
Type of post-operative hernias : evisceration, median hernia, parastomal hernia
Measured: 1 day
Define risk factors Type of risks factors
Define risk factors: sex, BMI, diabetes, ASA, duration surgery, delay, postoperative biology
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start30 Jan 2010
- Primary completion1 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evisceration; TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume Aujoulat, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626336
- Sponsor's protocol ID
- RECHMPL20_0604
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Hernias After Radical Cystectomy : Incidence and Risks Factors
- ClinicalTrials.gov ID
- NCT04626336
- Acronym / sponsor ID
- RECHMPL20_0604
- Conditions
- Evisceration; Traumatic, Hernia
- Keywords
- Median hernia, Parastomal hernia, Cystectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 30 Jan 2010 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who undergo a cystectomy | – | Procedure: CystectomyPatients who undergo a cystectomy for cancer or not, since 2010 to 2020 |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who undergo cystectomy for cancer or not at the CHU de Montpellier, Nîmes and the Beau Soleil clinic
Key inclusion criteria (2 listed)
- having undergone a cystectomy (for cancer or not),
- with or without reconstruction, between 01/01/2010 and 12/31/2020
Key exclusion criteria (1 listed)
- refusing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CystectomyCystectomy | Procedure or surgery | Patients who undergo a cystectomy |
Primary outcome
Type of post-operative hernias
Time frame: 1 day
Type of post-operative hernias : evisceration, median hernia, parastomal hernia
Define risk factors Type of risks factors
Time frame: 1 day
Define risk factors: sex, BMI, diabetes, ASA, duration surgery, delay, postoperative biology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Individual participant dataSharing planned: Undecided. NC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume Aujoulat principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evisceration; Traumatic and Hernia, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of post-operative hernias (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2020.