Unilateral Inguinal Hernia With Gangrene and ObstructionNCT02561910
Effectivity of Laparoscopic Inguinal Hernia Repair (TAPP) in Daily Clinical Practice - Early and Long-term Results
An observational study of Unilateral Inguinal Hernia With Gangrene and Obstruction, run by Hernia Center Rottenburg at 1 site in Germany.
Trial summary
The effectiveness of laparoscopic inguinal hernia repair still remains unclear. During a one year period a total of 1208 inguinal hernias in 952 patients were consecutively operated using the laparoscopic technique by a total of 11 general surgeons in daily clinical routine. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unilateral Inguinal Hernia With Gangrene and Obstruction
- What is being tested?
- Laparoscopic hernia repair
- Type of treatment
- Medical device
- How many people
- 952 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2000to Aug 2015
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients admitted for hernia surgery during a one year period (n=928) were operated exclusively in TAPP technique and were assigned to follow-up.
Who may be able to join
- All patients fit for general anesthesia and presenting an inguinal hernia.
Who cannot join
- Not fit for general anesthesia, young age (>21 years), not wanting a mesh.
Trial locations and contacts
1 site in 1 country.
About this study
The effectiveness of laparoscopic inguinal hernia repair still remains unclear. During a one year period a total of 1208 inguinal hernias in 952 patients were consecutively operated using the laparoscopic technique by a total of 11 general surgeons in daily clinical routine.
Laparoscopic hernia repair in the TAPP technique seems to have the potential to become the standard procedure in inguinal hernia repair in future.
Read the detailed description
Objective:
Hernia repair is the most frequent operation in general surgery worldwide, but about 25 years after the advent of minimal invasive surgical techniques the effectiveness of laparoscopic inguinal hernia repair still remains unclear.
Methods:
All patients admitted to the hospital for surgery of an inguinal hernia during a one year period were prospectively documented and included in a follow-up study. The follow-up was performed at least 5 years after surgery and consisted of a clinical examination, ultrasound investigation and a questionnaire.
- Being tested
- Laparoscopic hernia repair
- Keywords
- Inguinal hernia repair, laparoscopic inguinal hernia repair, TAPP
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic hernia repairDevice
Preperitoneal mesh implantation because of inguinal hernia disease using the laparoscopic technique
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of the trial was recurrence of a hernia within five years after the repair.
Measured: 5 years
Secondary outcomes (1)
The secondary outcome was chronic pain.
Chronic pain was measured by VAS scale
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startJan 2000
- Primary completionDec 2008
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unilateral Inguinal Hernia With Gangrene and ObstructionStudies 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
- 952 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hernia Center Rottenburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.Dr. Reinhard Bittner, Hernia Center Rottenburg
- Investigators
- Reinhard Bittner, M.D., Principal investigator, Hernia Center Rottenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561910
- Sponsor's protocol ID
- HerniaCR
- Status last verified
- Sep 2015
- First submitted
- 25 Sep 2015
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cavazzola LT, Rosen MJ. Laparoscopic versus open inguinal hernia repair. Surg Clin North Am. 2013 Oct;93(5):1269-79. doi: 10.1016/j.suc.2013.06.013.
PubMed 24035088
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectivity of Laparoscopic Inguinal Hernia Repair (TAPP) in Daily Clinical Practice - Early and Long-term Results
- ClinicalTrials.gov ID
- NCT02561910
- Acronym / sponsor ID
- HerniaCR
- Keywords
- Inguinal hernia repair, laparoscopic inguinal hernia repair, TAPP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 952 participants (actual)
- Lead sponsor
- Hernia Center RottenburgUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Dec 2008 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 28 Sep 2015 (estimated)
- 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 effectiveness of laparoscopic inguinal hernia repair still remains unclear. During a one year period a total of 1208 inguinal hernias in 952 patients were consecutively operated using the laparoscopic technique by a total of 11 general surgeons in daily clinical routine.
Laparoscopic hernia repair in the TAPP technique seems to have the potential to become the standard procedure in inguinal hernia repair in future.
Detailed description
Objective:
Hernia repair is the most frequent operation in general surgery worldwide, but about 25 years after the advent of minimal invasive surgical techniques the effectiveness of laparoscopic inguinal hernia repair still remains unclear.
Methods:
All patients admitted to the hospital for surgery of an inguinal hernia during a one year period were prospectively documented and included in a follow-up study. The follow-up was performed at least 5 years after surgery and consisted of a clinical examination, ultrasound investigation and a questionnaire.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted for hernia surgery during a one year period (n=928) were operated exclusively in TAPP technique and were assigned to follow-up.
Key inclusion criteria (1 listed)
- All patients fit for general anesthesia and presenting an inguinal hernia.
Key exclusion criteria (1 listed)
- Not fit for general anesthesia, young age (>21 years), not wanting a mesh.
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 hernia repairPreperitoneal mesh implantation because of inguinal hernia disease using the laparoscopic technique | Device | – |
Primary outcome
The primary outcome of the trial was recurrence of a hernia within five years after the repair.
Time frame: 5 years
1 secondary outcome
The secondary outcome was chronic pain.
Time frame: 5 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 28 Sep 2015.
- Background: PubMed 24035088Cavazzola LT, Rosen MJ. Laparoscopic versus open inguinal hernia repair. Surg Clin North Am. 2013 Oct;93(5):1269-79. doi: 10.1016/j.suc.2013.06.013.
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.
Reinhard Bittner, M.D. principal investigator
Hernia Center Rottenburg
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 Unilateral Inguinal Hernia With Gangrene and Obstruction, run by Hernia Center Rottenburg at 1 site in Germany.
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 28 Sep 2015. 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 Germany. 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?
The primary outcome of the trial was recurrence of a hernia within five years after the repair. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02561910, which also lists 1 linked publication.
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 28 Sep 2015.