Inguinal HerniaPOINTHERNCT04806828
Preoperative Score of Inguinal Hernias. Is it Useful to Predict Outcomes
An observational study of Inguinal Hernia, run by Hospital del Mar at 1 site in Spain.
Trial summary
To analyze and validate a preoperative score of difficulty of inguinal hernias and its correlation with postoperative outcomes Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Preoperative classification
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 13 Sep 2021
- How long will I take part?
- 30 Days
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients scheduled for a primary repair of inguinal hernia
Who may be able to join
- Male sex
- Age > 18 years
- Primary inguinal hernia
- Unilateral hernia
- Elective surgery
Who cannot join
- Recurrent inguinal hernia
Trial locations and contacts
1 site in 1 country.
About this study
To analyze and validate a preoperative score of difficulty of inguinal hernias and its correlation with postoperative outcomes
- Conditions
- Inguinal Hernia
- Being tested
- Preoperative classification
- Keywords
- Inguinal Hernia, Preoperative Score, Kingsnorth Score
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative classificationOther
Score of inguinal hernia
| Study group | Role | What they receive |
|---|---|---|
| HF | Preoperative classification of inguinal hernia Receives: Other: Preoperative classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Rate of postoperative complications
Measured: 30 days
Secondary outcomes (2)
Lenght of operation
Minutes of operation
Measured: Intraoperative
Recurrences
Recurrences during follow-up
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Jan 2019
- Primary completion1 Jan 2021
- Study completion13 Sep 2021
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
- Prospective
- Enrolment
- 400 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, José A. Pereira, Hospital del Mar
- Investigators
- José Antonio Pereira, Principal investigator, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806828
- Sponsor's protocol ID
- POINTHER
- Acronym
- POINTHER
- Status last verified
- Sep 2021
- First submitted
- 11 Mar 2021
- Last updated
- 14 Sep 2021
- 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 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Score of Inguinal Hernias. Is it Useful to Predict Outcomes
- ClinicalTrials.gov ID
- NCT04806828
- Acronym / sponsor ID
- POINTHER / POINTHER
- Conditions
- Inguinal Hernia
- Keywords
- Inguinal Hernia, Preoperative Score, Kingsnorth Score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 13 Sep 2021 (actual)
- First posted
- 19 Mar 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.
To analyze and validate a preoperative score of difficulty of inguinal hernias and its correlation with postoperative outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HF | – | Other: Preoperative classificationPreoperative classification of inguinal hernia |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled for a primary repair of inguinal hernia
Key inclusion criteria (5 listed)
- Male sex
- Age > 18 years
- Primary inguinal hernia
- Unilateral hernia
- Elective surgery
Key exclusion criteria (1 listed)
- Recurrent inguinal 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 |
|---|---|---|
| Preoperative classificationScore of inguinal hernia | Other | HF |
Primary outcome
Postoperative complications
Time frame: 30 days
Rate of postoperative complications
2 secondary outcomes
Lenght of operation
Time frame: Intraoperative
Recurrences
Time frame: 1 year
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 14 Sep 2021.
- 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.
José Antonio Pereira principal investigator
Parc de Salut Mar
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, run by Hospital del Mar at 1 site in Spain.
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 5 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 14 Sep 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 Spain. 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?
Postoperative complications (time frame: 30 days). 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 14 Sep 2021.