Consensus in Surgical Community for Asymptomatic Abdominal Wall and Incisional Hernias

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Completed
• CT.gov ID: NCT04434573
• Collaborator: (none)
• Enrollment: 204
• Location: 1
• Actual Duration (Months): 5
• Patients Per Site Per Month: 41.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Study of Practices of Surgeons on Surgical Management of Asymptomatic Hernias; Comparison With International Recommendations	Other: Observation study

Study Design

• Study Type: Observational
• Actual Enrollment: 204 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Asymptomatic Abdominal Wall and Incisional Hernias: Is Therapeutic Decision Consensual An International Survey
• Actual Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	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.	Other: Observation study; 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.

Outcome Measures

Primary Outcome Measures

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 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

Exclusion Criteria:

• No

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Gustave Roussy	Villejuif	Ile De France	France	94800

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT04434573
• Other Study ID Numbers: 20_213
• First Posted: Jun 17, 2020
• Last Update Posted: Jun 17, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hernia; Incisional Hernia

Study Results

No Results Posted as of Jun 17, 2020