NCT04434573

Brief 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. The objective of this study was to evaluate the practices of a large population of digestive surgeons with asymptomatic hernia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
204

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

June 12, 2020

Last Update Submit

June 12, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    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

Study Arms (1)

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.

Other: Observation study

Interventions

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.

french-speaking digestive surgeons

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

French-speaking surgeons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, Île-de-France Region, 94800, France

Location

MeSH Terms

Interventions

Observational Studies as Topic

Intervention Hierarchy (Ancestors)

Clinical Studies as TopicEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

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

Study Record Dates

First Submitted

June 12, 2020

First Posted

June 17, 2020

Study Start

October 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

June 17, 2020

Record last verified: 2020-06

Locations