Study of Practices of Surgeons on Surgical Management of Asymptomatic HerniasNCT04434573
Consensus in Surgical Community for Asymptomatic Abdominal Wall and Incisional Hernias
An observational study of Study of Practices of Surgeons on Surgical Management of Asymptomatic Hernias and Comparison With International Recommendations, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Study of Practices of Surgeons on Surgical Management of Asymptomatic Hernias, Comparison With International Recommendations
- What is being tested?
- Observation study
- How many people
- 204 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Mar 2017
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: French-speaking surgeons
Who may be able to join
- -
Who cannot join
- No
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Study of Practices of Surgeons on Surgical Management of Asymptomatic Hernias, Comparison With International Recommendations
- Being tested
- Observation study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation studyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observation study |
What is being measured
The primary outcome is the main question the study is designed to answer.
number and type of clinical cases for which a consensus, defined by an arbitrary value of 75% of surgeons with the same therapeutic attitude
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study startOct 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Study of Practices of Surgeons on Surgical Management of Asymptomatic HerniasStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434573
- Sponsor's protocol ID
- 20_213
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asymptomatic Abdominal Wall and Incisional Hernias: Is Therapeutic Decision Consensual An International Survey
- ClinicalTrials.gov ID
- NCT04434573
- Acronym / sponsor ID
- 20_213
- Conditions
- Study of Practices of Surgeons on Surgical Management of Asymptomatic Hernias, Comparison With International Recommendations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 17 Jun 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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| french-speaking digestive surgeons | – | Other: Observation studyfrench-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- French-speaking surgeons
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| Observation studyFrench-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. | Other | french-speaking digestive surgeons |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Study of Practices of Surgeons on Surgical Management of Asymptomatic Hernias and Comparison With International Recommendations, run by Hospices Civils de Lyon 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 1 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: finished, as of the sponsor's last update on 17 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 17 Jun 2020.