Hernia, InguinalherniaNCT04683367
Follow-up of Symptomless Inguinal and Ventral Hernias
A study testing laparoscopic surgery in people with Hernia, Inguinal and Hernia, Ventral, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
The orifices of all inguinal and ventral (including Spigelian) hernias were carefully recorded at the beginning of laparoscopy (n=201) of other reason (cholecystectomy, fundoplication) in 2003-5. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hernia, Inguinal, Hernia, Ventral, Laparoscopy
- What is being tested?
- laparoscopic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2003to 30 Nov 2020
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- occult inguinal or ventral hernia diagnosed in laparoscopic surgery
Who cannot join
- clinically diagnosed inguinal or ventral hernia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 15-year Follow-up of Laparoscopically Diagnosed Occult Inguinal and Ventral Hernias
The orifices of all inguinal and ventral (including Spigelian) hernias were carefully recorded at the beginning of laparoscopy (n=201) of other reason (cholecystectomy, fundoplication) in 2003-5. The patients with occult hernias (n=43) were followed-up 15 years to find out what percentage of hernias would become symptomatic.
Read the detailed description
This was a prospective laparoscopic study of 201 consecutive adult patients operated in 2003-5. There were 133 females and 68 males with a mean age 53 ± 14 years. The index laparoscopic operation included 104 cholecystectomies, 55 fundoplications, 36 diagnostic, 5 appendectomies and one insertion of peritoneal catheter. A careful clinical examination of the groin and ventral region was performed on everybody and all patients with clinical hernias were excluded. Laparoscopic exploration of the inguinal region was considered safe and did not greatly increase the operative time. All patients were informed that hernial orifices would be explored during laparoscopy, and a written consent was asked prior to surgery. Permission to repair large hernias (> 1 cm) was also obtained before laparoscopy.
The patients were followed-up 15 years to find out, what percentage of occult, symptomless inguinal and ventral hernias were later operated because of harmfull symptoms.
- Conditions
- Hernia, Inguinal, Hernia, Ventral, Laparoscopy
- Being tested
- laparoscopic surgery
- Keywords
- inguinal hernia, ventral hernia, laparoscopic diagnosis
- Medical subject headings
- Hernia, Inguinal, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic surgeryProcedure or surgery
Also called hernioplasty
laparoscopic repair of hernia
| Study group | Role | What they receive |
|---|---|---|
| clinical hernia | Experimental | developing clinical hernia Receives: Procedure: laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of operated hernia
occult hernia operated because of symptoms
Measured: 15 years
Secondary outcomes (1)
number of symptomatic hernia
incipient, asymptomatic hernia becomes symptomatic during follow-up
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start1 Jan 2003
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hannu Paajanen, Kuopio University Hospital
- Investigators
- Hannu EK Paajanen, MD, PhD, Principal investigator, department of Surgery, Kuopio Univ Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683367
- Sponsor's protocol ID
- 139/2020
- Acronym
- hernia
- Status last verified
- Dec 2020
- First submitted
- 16 Dec 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 15-year Follow-up of Laparoscopically Diagnosed Occult Inguinal and Ventral Hernias
- ClinicalTrials.gov ID
- NCT04683367
- Acronym / sponsor ID
- hernia / 139/2020
- Conditions
- Hernia, Inguinal, Hernia, Ventral, Laparoscopy
- Keywords
- inguinal hernia, ventral hernia, laparoscopic diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2003 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 24 Dec 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.
The orifices of all inguinal and ventral (including Spigelian) hernias were carefully recorded at the beginning of laparoscopy (n=201) of other reason (cholecystectomy, fundoplication) in 2003-5. The patients with occult hernias (n=43) were followed-up 15 years to find out what percentage of hernias would become symptomatic.
Detailed description
This was a prospective laparoscopic study of 201 consecutive adult patients operated in 2003-5. There were 133 females and 68 males with a mean age 53 ± 14 years. The index laparoscopic operation included 104 cholecystectomies, 55 fundoplications, 36 diagnostic, 5 appendectomies and one insertion of peritoneal catheter. A careful clinical examination of the groin and ventral region was performed on everybody and all patients with clinical hernias were excluded. Laparoscopic exploration of the inguinal region was considered safe and did not greatly increase the operative time. All patients were informed that hernial orifices would be explored during laparoscopy, and a written consent was asked prior to surgery. Permission to repair large hernias (> 1 cm) was also obtained before laparoscopy.
The patients were followed-up 15 years to find out, what percentage of occult, symptomless inguinal and ventral hernias were later operated because of harmfull symptoms.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clinical hernia | Experimental | Procedure: laparoscopic surgerydeveloping clinical hernia |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- occult inguinal or ventral hernia diagnosed in laparoscopic surgery
Key exclusion criteria (1 listed)
- clinically diagnosed inguinal or ventral hernia
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 |
|---|---|---|
| laparoscopic surgeryAlso: hernioplastylaparoscopic repair of hernia | Procedure or surgery | clinical hernia |
Primary outcome
number of operated hernia
Time frame: 15 years
occult hernia operated because of symptoms
1 secondary outcome
number of symptomatic hernia
Time frame: 15 years
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 24 Dec 2020.
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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.
Hannu EK Paajanen, MD, PhD principal investigator
department of Surgery, Kuopio Univ Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic surgery in people with Hernia, Inguinal and Hernia, Ventral, run by Kuopio University Hospital at 1 site in Finland.
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 24 Dec 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 Finland. 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 of operated hernia (time frame: 15 years). 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 24 Dec 2020.