Abdominal HerniaNCT04435340
Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh
A study testing Selective Sonography of the ventral abdominal hernia level in people with Abdominal Hernia, run by Spital Limmattal Schlieren at 1 site in Switzerland.
Trial summary
Patients who underwent ventral abdominal hernia repair with self adhering, atraumatic mesh in sublay position are examined for their recurrence rate Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Hernia
- What is being tested?
- Selective Sonography of the ventral abdominal hernia level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Mar 2018to 31 Dec 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18 years
- Initially suffering from ventral abdominal hernia
- Performance of open ventral abdominal hernia repair with self-adhering, atraumatic mesh (Adhesix ®)
- Informed Consent as documented by signature (Appendix: Informed Consent Form)
Who cannot join
- Inability to comply with the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Sonographic Outcome After Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh in the Retro-rectus (Sublay) Position
Patients who underwent ventral abdominal hernia repair with self adhering, atraumatic mesh in sublay position are examined for their recurrence rate
Read the detailed description
The study includes all patients operated from 11.03.2014 to 31.12.2020. Patients will undergo a Sonography at least one year after surgery. The patients operated form 11.03.2014 to date are therefore a retrospective cohort, the patients from to date until 31.12.2020 a prospective cohort. This method is used to achieve the highest possible number of patients in a define period of time with no alteration of surgical technique.
All patients in the retrospective cohort are contacted at least 1 year after surgery and/or 3 years after surg ery via phone call or letter, informed about the study and asked to participate. In case of informed consent, they are invited to the study site. They are asked to complete the questionnaires and they undergo a Sonography of the ventral abdomen.
All patients in the prospective cohort are informed about the study and asked to participate in the outpatient clinic before surgery. In case of informed consent, they are invited to the study site at least one year and three years, respectively, after surgery. They are asked to complete the questionnaires and they undergo an ultrasound of the ventral abdomen.
The latest follow up should be completed by 31.03.2022.
For both, the retro- and prospective arm, the time needed for the follow-up appointment is approximately 1 hour. The completion of the ultrasound is estimated to take 20 minutes, the questionnaires is estimated to take 20-30 minutes.
- Conditions
- Abdominal Hernia
- Being tested
- Selective Sonography of the ventral abdominal hernia level
- Keywords
- Abdominal Hernia, Ventral Hernia, Atraumatic mesh
- Medical subject headings
- Hernia, Abdominal, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Sonography of the ventral abdominal hernia levelDiagnostic test
The primary outcome of the study is measured by an radiologist experienced in abdominal ultrasound with a linear ultrasound transducer (ML 6-15 Hz). In case of aggravated examination circumstances a different ultrasound transducer is used (linear 9 L or convex C 1-6 Hz)
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | Other | All patients in the retrospective cohort are contacted at least 1 year after surgery and/or 3 years after surgery via phone call or letter, informed about the study and asked to participate. In case of informed consent, they are invited to the study site. They are asked to complete the questionnaires and they undergo a Sonography of the ventral abdomen. Receives: Diagnostic Test: Selective Sonography of the ventral abdominal hernia level |
| Prospective | Other | All patients in the prospective cohort are informed about the study and asked to participate in the outpatient clinic before surgery. In case of informed consent, they are invited to the study site at least one year and three years, respectively, after surgery. They are asked to complete the questionnaires and they undergo an ultrasound of the ventral abdomen. Receives: Diagnostic Test: Selective Sonography of the ventral abdominal hernia level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrance rate in sonography
The primary outcome is the recurrence rate of ventral abdominal hernia determined by clinical examination and sonography. A recurrence is defined if intraabdominal structures (i.e. intestines, omentum, preperitoneal fat tissue) reach ventrally of the facial layers .
Measured: 12 months after surgery
Recurrance rate clinically
The primary outcome is the recurrence rate of ventral abdominal hernia determined by clinical examination. A recurrence is defined if intraabdominal structures (i.e. intestines, omentum, preperitoneal fat tissue) reach ventrally of the facial layers .
Measured: 12 months after surgery
Secondary outcomes (3)
Pain and sensation of the mesh measured by the Carolinas Comfort Scale questionnaire
Clinical subjective outcome 1
Measured: 12 months after surgery
Limitations in quality of life questionnaire
Clinical subjective outcome 2
Measured: 12 months after surgery
Daily activities measured HerQLes questionnaire
Clinical subjective outcome 3
Measured: 12 months after surgery
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 start22 Mar 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- retro- and prospective arm
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spital Limmattal Schlieren
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Urs Zingg, Spital Limmattal Schlieren
- Investigators
- Urs Zingg, Study chair, Spital Limmattal Schlieren
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435340
- Sponsor's protocol ID
- 2018-00122
- Other IDs
- 2018
- Status last verified
- Apr 2023
- First submitted
- 7 Jan 2020
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Sonographic Outcome After Ventral Abdominal Hernia Repair With Self Adhering, Atraumatic Mesh in the Retro-rectus (Sublay) Position
- ClinicalTrials.gov ID
- NCT04435340
- Acronym / sponsor ID
- 2018-00122
- Conditions
- Abdominal Hernia
- Keywords
- Abdominal Hernia, Ventral Hernia, Atraumatic mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Spital Limmattal SchlierenUniversity, hospital or other
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (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.
Patients who underwent ventral abdominal hernia repair with self adhering, atraumatic mesh in sublay position are examined for their recurrence rate
Detailed description
The study includes all patients operated from 11.03.2014 to 31.12.2020. Patients will undergo a Sonography at least one year after surgery. The patients operated form 11.03.2014 to date are therefore a retrospective cohort, the patients from to date until 31.12.2020 a prospective cohort. This method is used to achieve the highest possible number of patients in a define period of time with no alteration of surgical technique.
All patients in the retrospective cohort are contacted at least 1 year after surgery and/or 3 years after surg ery via phone call or letter, informed about the study and asked to participate. In case of informed consent, they are invited to the study site. They are asked to complete the questionnaires and they undergo a Sonography of the ventral abdomen.
All patients in the prospective cohort are informed about the study and asked to participate in the outpatient clinic before surgery. In case of informed consent, they are invited to the study site at least one year and three years, respectively, after surgery. They are asked to complete the questionnaires and they undergo an ultrasound of the ventral abdomen.
The latest follow up should be completed by 31.03.2022.
For both, the retro- and prospective arm, the time needed for the follow-up appointment is approximately 1 hour. The completion of the ultrasound is estimated to take 20 minutes, the questionnaires is estimated to take 20-30 minutes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- retro- and prospective arm
| Arm | Type | Receives |
|---|---|---|
| Retrospective | Other | Diagnostic Test: Selective Sonography of the ventral abdominal hernia levelAll patients in the retrospective cohort are contacted at least 1 year after surgery and/or 3 years after surgery via phone call or letter, informed about the study and asked to participate. In case of informed consent, they are invited to the study site. They are asked to complete the questionnaires and they undergo a Sonography of the ventral abdomen. |
| Prospective | Other | Diagnostic Test: Selective Sonography of the ventral abdominal hernia levelAll patients in the prospective cohort are informed about the study and asked to participate in the outpatient clinic before surgery. In case of informed consent, they are invited to the study site at least one year and three years, respectively, after surgery. They are asked to complete the questionnaires and they undergo an ultrasound of the ventral abdomen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age older than 18 years
- Initially suffering from ventral abdominal hernia
- Performance of open ventral abdominal hernia repair with self-adhering, atraumatic mesh (Adhesix ®)
- Informed Consent as documented by signature (Appendix: Informed Consent Form)
Key exclusion criteria (1 listed)
- Inability to comply with the study protocol
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 |
|---|---|---|
| Selective Sonography of the ventral abdominal hernia levelThe primary outcome of the study is measured by an radiologist experienced in abdominal ultrasound with a linear ultrasound transducer (ML 6-15 Hz). In case of aggravated examination circumstances a different ultrasound transducer is used (linear 9 L or convex C 1-6 Hz) | Diagnostic test | Prospective, Retrospective |
Primary outcome
Recurrance rate in sonography
Time frame: 12 months after surgery
The primary outcome is the recurrence rate of ventral abdominal hernia determined by clinical examination and sonography. A recurrence is defined if intraabdominal structures (i.e. intestines, omentum, preperitoneal fat tissue) reach ventrally of the facial layers .
Recurrance rate clinically
Time frame: 12 months after surgery
The primary outcome is the recurrence rate of ventral abdominal hernia determined by clinical examination. A recurrence is defined if intraabdominal structures (i.e. intestines, omentum, preperitoneal fat tissue) reach ventrally of the facial layers .
3 secondary outcomes
Pain and sensation of the mesh measured by the Carolinas Comfort Scale questionnaire
Time frame: 12 months after surgery
Limitations in quality of life questionnaire
Time frame: 12 months after surgery
Daily activities measured HerQLes questionnaire
Time frame: 12 months after surgery
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 13 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Urs Zingg study chair
Spital Limmattal Schlieren
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective Sonography of the ventral abdominal hernia level in people with Abdominal Hernia, run by Spital Limmattal Schlieren at 1 site in Switzerland.
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 4 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 13 Apr 2023. 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 Switzerland. 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?
Recurrance rate in sonography (time frame: 12 months after surgery). 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 13 Apr 2023.