Hernia, InguinalNCT03155230
Nationwide Results on Chronic Pain After Bilateral Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP)
An observational study of Hernia, Inguinal and Chronic Pain, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Danish male patients who had undergone bilateral TAPP (July 2012 to June 2013) were recruited from the Danish Hernia Database and cross-checked with hospital files and the National Patient Registry. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hernia, Inguinal, Chronic Pain
- How many people
- 209 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2015to 25 Oct 2017
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Danish males, age>18 years undergoing elective, bilateral TAPP due to inguinal hernia (medial, lateral, and combined hernias) within the study period from July 1, 2012 to June 30 2013
Who may be able to join
- Danish males,
- Age>18 years
- Elective, bilateral TAPP due to inguinal hernia within the period from July 1, 2012 to June 30 2013
Who cannot join
- age <18 years
- miss-classified surgical code
- non-Danish speaking
- psychiatric anamneses
- regarded and non-compliant patients who had either died, emigrated or were lost to follow-up emergency repair
- femoral hernia repair
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Gastrounit, Surgical Division, Hvidovre Hospital, Denmark
Copenhagen, Danmark, 6000
About this study
Danish male patients who had undergone bilateral TAPP (July 2012 to June 2013) were recruited from the Danish Hernia Database and cross-checked with hospital files and the National Patient Registry. A standardized postal questionnaire was sent out two years after the index surgery to investigate Patients Related Outcome Measures (PROMs) such as chronic post-operative pain.
Read the detailed description
The present study was primarily undertaken to provide evidence for the risk of activity-related chronic postoperative inguinal pain following bilateral TAPP in an all-male Danish setting. Impaired sexual activity and sleep disturbance due to pain was also recorded. Data based on nationwide consecutive patients undergoing bilateral TAPP. Data collected for the Danish Inguinal Hernia Database, hospital files and the National Patient Registry (Denmark).
- Conditions
- Hernia, Inguinal, Chronic Pain
- Being tested
- no intervention
- Keywords
- Inguinal hernia
- Medical subject headings
- Hernia, Inguinal, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Activities Assessment Scale Questionnaire
Impaired daily activities by chronic pain from either one or both groin areas
Measured: Within one week
Secondary outcomes (2)
Questionnaire about sexual impairment
Sexual impairment due to chronic pain from either one or both groin areas
Measured: Within three months
Questionnaire about sleep impairment
Sleep impairment due to chronic pain from either one or both groin areas
Measured: Within three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Jan 2015
- Primary completion1 Jul 2017
- Study completion25 Oct 2017
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niels Johansen, Hvidovre University Hospital
- Investigators
- Thue Bisgaard, professor, Study director, HvidovreUT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155230
- Sponsor's protocol ID
- nj01042017
- Status last verified
- Mar 2019
- First submitted
- 14 May 2017
- Last updated
- 25 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nationwide Results on Chronic Pain After Bilateral Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP)
- ClinicalTrials.gov ID
- NCT03155230
- Acronym / sponsor ID
- nj01042017
- Conditions
- Hernia, Inguinal, Chronic Pain
- Keywords
- Inguinal hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 16 May 2017 (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.
Danish male patients who had undergone bilateral TAPP (July 2012 to June 2013) were recruited from the Danish Hernia Database and cross-checked with hospital files and the National Patient Registry. A standardized postal questionnaire was sent out two years after the index surgery to investigate Patients Related Outcome Measures (PROMs) such as chronic post-operative pain.
Detailed description
The present study was primarily undertaken to provide evidence for the risk of activity-related chronic postoperative inguinal pain following bilateral TAPP in an all-male Danish setting. Impaired sexual activity and sleep disturbance due to pain was also recorded. Data based on nationwide consecutive patients undergoing bilateral TAPP. Data collected for the Danish Inguinal Hernia Database, hospital files and the National Patient Registry (Denmark).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Danish males, age>18 years undergoing elective, bilateral TAPP due to inguinal hernia (medial, lateral, and combined hernias) within the study period from July 1, 2012 to June 30 2013
Key inclusion criteria (3 listed)
- Danish males,
- Age>18 years
- Elective, bilateral TAPP due to inguinal hernia within the period from July 1, 2012 to June 30 2013
Key exclusion criteria (6 listed)
- age <18 years
- miss-classified surgical code
- non-Danish speaking
- psychiatric anamneses
- regarded and non-compliant patients who had either died, emigrated or were lost to follow-up emergency repair
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 |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Activities Assessment Scale Questionnaire
Time frame: Within one week
Impaired daily activities by chronic pain from either one or both groin areas
2 secondary outcomes
Questionnaire about sexual impairment
Time frame: Within three months
Questionnaire about sleep impairment
Time frame: Within three months
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 25 Mar 2019.
Related trials for Hernia, Inguinal
Recruiting
Permanent Versus Slowly Dissolving Stitches for Non-Mesh (Shouldice) Groin Hernia Repair
Inguinal Hernia
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Primary Sac Abandonment and Distal Sac Fixation vs Complete Sac Dissection for Inguinoscrotal Hernias
Seroma, Inguinal Hernias
Recruiting
Comparing Two Laparoscopic Techniques for Hernia Repair in Children
Inguinal Hernia
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
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.
Thue Bisgaard, professor study director
HvidovreUT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Inguinal and Chronic Pain, run by Hvidovre University Hospital at 1 site in Denmark.
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 3 inclusion and 6 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 25 Mar 2019. 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 Denmark. 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?
Activities Assessment Scale Questionnaire (time frame: Within one week). 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 25 Mar 2019.