Inguinal HerniaNCT04888078
Bassini Inguinal Hernia Repair: Obsolete Or Still A Viable Surgical Option?
An observational study of Inguinal Hernia and Surgery--Complications, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
Trial summary
Retrospective review of hernia surgery patients at HHMcGuire VAMC focusing on repair type and postoperative complications. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia, Surgery--Complications, Surgical Complication
- What is being tested?
- Bassini hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2006to 31 Dec 2019
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Veterans who underwent inguinal hernia repair without mesh
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Hunter Holmes McGuire VAMC
Richmond, Virginia, 23249
About this study
Official title: Incidence of POUR in the Veteran Population After Elective Inguinal Hernia Repair: A Retrospective Study
Retrospective review of hernia surgery patients at HHMcGuire VAMC focusing on repair type and postoperative complications.
- Being tested
- Bassini hernia repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bassini hernia repairProcedure or surgery
Non-mesh tissue inguinal hernia repairs
What is being measured
The primary outcome is the main question the study is designed to answer.
Inguinal hernia recurrence
chart review
Measured: 5-13 years postoperatively
Secondary outcomes (5)
wound infection
chart review
Measured: 5-13 years
urinary retention
chart review
Measured: 5-13 years
groin pain
chart review
Measured: 5-13 years
durability of repair
chart review
Measured: 5-13 years postop
testicular ischemia
chart review
Measured: 5-13 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Jan 2006
- Primary completion31 Dec 2014
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jeannie Rivers, Hunter Holmes Mcguire Veteran Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888078
- Sponsor's protocol ID
- 02331
- Status last verified
- May 2021
- First submitted
- 11 May 2021
- Last updated
- 17 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All personally identifiable information is secured. Study outcomes reported in aggregate only.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of POUR in the Veteran Population After Elective Inguinal Hernia Repair: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04888078
- Acronym / sponsor ID
- 02331
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Study start
- 1 Jan 2006 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 May 2021 (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.
Retrospective review of hernia surgery patients at HHMcGuire VAMC focusing on repair type and postoperative complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans who underwent inguinal hernia repair without mesh
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Bassini hernia repairNon-mesh tissue inguinal hernia repairs | Procedure or surgery | – |
Primary outcome
Inguinal hernia recurrence
Time frame: 5-13 years postoperatively
chart review
5 secondary outcomes
wound infection
Time frame: 5-13 years
urinary retention
Time frame: 5-13 years
groin pain
Time frame: 5-13 years
durability of repair
Time frame: 5-13 years postop
testicular ischemia
Time frame: 5-13 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 17 May 2021.
- Individual participant dataSharing planned: No. All personally identifiable information is secured. Study outcomes reported in aggregate only.
Related trials for Inguinal Hernia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Inguinal Hernia and Surgery--Complications, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
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 0 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 17 May 2021. 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 United States. 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?
Inguinal hernia recurrence (time frame: 5-13 years postoperatively). 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 17 May 2021.