- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04434573
Consensus in Surgical Community for Asymptomatic Abdominal Wall and Incisional Hernias
June 12, 2020 updated by: Hospices Civils de Lyon
Asymptomatic Abdominal Wall and Incisional Hernias: Is Therapeutic Decision Consensual An International Survey
Hernia pathology is one of the leading causes of surgery worldwide.
For asymptomatic patients, surgery remains questionable.
Although there are new European recommendations, the practice of digestive surgeons regarding the management of asymptomatic hernias is unknown.
The objective of this study was to evaluate the practices of a large population of digestive surgeons with asymptomatic hernia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
204
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ile De France
-
Villejuif, Ile De France, France, 94800
- Institut Gustave Roussy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
French-speaking surgeons
Description
Inclusion Criteria:
-
Exclusion Criteria:
- No
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
french-speaking digestive surgeons
french-speaking digestive surgeons are visceral and digestive surgeons that have a general surgical activity too.
They can have or not an expertise on hernia pathology.
They are questioned by survey on decisions about different patient asymptomatic hernia clinical situations.
|
French-speaking digestive surgeons are invited to respond to an online survey consisting of 13 common clinical situations concerning primary or asymptomatic incisional hernia pathology where a therapeutic decision is requested.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number and type of clinical cases for which a consensus, defined by an arbitrary value of 75% of surgeons with the same therapeutic attitude
Time Frame: The outcome measure is evaluated after 6 months during which the survey is online (from october 2016 to march 2017), time during which surgeons had access to answer it
|
The survey consists of general questions about the surgeons' activity and then 13 clinical situations where a decision is requested.
The clinical cases are developed by the authors of the study in order to solve the frequent problems with the treatment of hernias and incisional hernias
|
The outcome measure is evaluated after 6 months during which the survey is online (from october 2016 to march 2017), time during which surgeons had access to answer it
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
June 12, 2020
First Submitted That Met QC Criteria
June 12, 2020
First Posted (Actual)
June 17, 2020
Study Record Updates
Last Update Posted (Actual)
June 17, 2020
Last Update Submitted That Met QC Criteria
June 12, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20_213
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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