Incisional HerniaNCT04013009
Laparotomy Closure Techniques: do Surgeons Follow the Latest Guidelines? Results of a Questionnaire.
An observational study of Incisional Hernia and Laparotomy Closure Technique, run by VieCuri Medical Centre.
Trial summary
Incisional hernias after laparotomy are associated with significant morbidity and increased costs. Research is focused on development of new techniques to prevent incisional hernia. Little is known about application of this evidence in daily practice. Therefore, a survey was performed among Dutch surgeons. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Incisional Hernia, Laparotomy Closure Technique
- How many people
- 402 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 31 Dec 2016
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Surgeons in the Netherlands
Who may be able to join
- surgeon in the Netherlands
Who cannot join
- not practicing surgery
- not practicing in the Netherlands
About this study
Incisional hernias after laparotomy are associated with significant morbidity and increased costs. Research is focused on development of new techniques to prevent incisional hernia. Little is known about application of this evidence in daily practice. Therefore, a survey was performed among Dutch surgeons.
Read the detailed description
Incisional hernias after laparotomy are associated with significant morbidity and increased costs. Research is focused on development of new techniques to prevent incisional hernia. Little is known about application of this evidence in daily practice. Therefore, a survey was performed among Dutch surgeons.
All members of the Dutch Surgical Society were invited to participate in a 24-question online survey on techniques and materials used for abdominal wall closure after midline laparotomy. Subgroup analysis based on surgical subspecialty, hospital and experience was performed.
- Conditions
- Incisional Hernia, Laparotomy Closure Technique
- Keywords
- incisional hernia, prevention, laparotomy closure, quality improvement, survey, guideline
- Medical subject headings
- Incisional Hernia
What is being measured
The primary outcome is the main question the study is designed to answer.
opinions on and current technique used for laparotomy closure
multiple choice questions
Measured: July till August 2016 at survey completion; snapshot measurement
knowledge of incisional hernia development
multiple choice questions
Measured: July till August 2016 at survey completion; ; snapshot measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start1 Jul 2016
- Primary completion31 Aug 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incisional HerniaStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 402 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- VieCuri Medical Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center
- Responsible party
- Principal investigator, Arthur Bloemen, VieCuri Medical Centre
- Investigators
- Arthur Bloemen, MD, Principal investigator, VieCuri Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013009
- Sponsor's protocol ID
- 01
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: anonymous individual data will be provided upon request
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparotomy Closure Techniques: do Surgeons Follow the Latest Guidelines? Results of a Questionnaire.
- ClinicalTrials.gov ID
- NCT04013009
- Acronym / sponsor ID
- 01
- Conditions
- Incisional Hernia, Laparotomy Closure Technique
- Keywords
- incisional hernia, prevention, laparotomy closure, quality improvement, survey, guideline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 402 participants (actual)
- Lead sponsor
- VieCuri Medical CentreUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 9 Jul 2019 (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.
Incisional hernias after laparotomy are associated with significant morbidity and increased costs. Research is focused on development of new techniques to prevent incisional hernia. Little is known about application of this evidence in daily practice. Therefore, a survey was performed among Dutch surgeons.
Detailed description
Incisional hernias after laparotomy are associated with significant morbidity and increased costs. Research is focused on development of new techniques to prevent incisional hernia. Little is known about application of this evidence in daily practice. Therefore, a survey was performed among Dutch surgeons.
All members of the Dutch Surgical Society were invited to participate in a 24-question online survey on techniques and materials used for abdominal wall closure after midline laparotomy. Subgroup analysis based on surgical subspecialty, hospital and experience was performed.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Surgeons in the Netherlands
Key inclusion criteria (1 listed)
- surgeon in the Netherlands
Key exclusion criteria (2 listed)
- not practicing surgery
- not practicing in the Netherlands
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
opinions on and current technique used for laparotomy closure
Time frame: July till August 2016 at survey completion; snapshot measurement
multiple choice questions
knowledge of incisional hernia development
Time frame: July till August 2016 at survey completion; ; snapshot measurement
multiple choice questions
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 9 Jul 2019.
- Individual participant dataSharing planned: Undecided. anonymous individual data will be provided upon request
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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.
Arthur Bloemen, MD principal investigator
VieCuri Medical Centre
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia and Laparotomy Closure Technique, run by VieCuri Medical Centre.
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 2 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 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
opinions on and current technique used for laparotomy closure (time frame: July till August 2016 at survey completion; snapshot measurement). 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 9 Jul 2019.