Inguinal HerniaPINENCT04328597
Portuguese Inguinal Hernia Cohort (PINE) Study
An observational study of Inguinal Hernia and Chronic Pain, run by Portuguese Surgical Research Collaborative at 1 site in Portugal.
Trial summary
Prospective national cohort study of patients submitted to elective inguinal hernia repair. The primary outcome is the prevalence of chronic postoperative inguinal pain, according to the EuraHS QoL questionnaire at 3 months postoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia, Chronic Pain
- What is being tested?
- Inguinal hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 sitePortugal
- Study dates
- 7 Oct 2019to 12 Aug 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Portuguese patients undergoing inguinal hernia repair in one of the hospitals participating in the study
Who may be able to join
- Elective inguinal hernia repair in a portuguese hospital
- Willing and able to consent and comply with the follow up protocol
Who cannot join
- Urgent/emergent inguinal hernia repair
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Portuguese Inguinal Hernia Cohort Study
Prospective national cohort study of patients submitted to elective inguinal hernia repair. The primary outcome is the prevalence of chronic postoperative inguinal pain, according to the EuraHS QoL questionnaire at 3 months postoperatively. The study will be delivered in all Portuguese regions through a collaborative research network. Four 2-week inclusion periods will be open for recruitment. A site-specific questionnaire will capture procedure volume and logistical facilities for hernia surgery.
- Conditions
- Inguinal Hernia, Chronic Pain
- Being tested
- Inguinal hernia repair
- 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.
Inguinal hernia repairProcedure or surgery
Also called surgery
Inguinal hernia repair (open, laparo-endoscopic, robotic)
| Study group | Role | What they receive |
|---|---|---|
| Chronic postoperative pain | Patients scoring 3 or more on the EuraHS Quality of Life assessment after elective inguinal hernia repair Receives: Procedure: Inguinal hernia repair | |
| Non chronic postoperative pain | Patients scoring less than 3 on the EuraHS Quality of Life assessment after elective inguinal hernia repair Receives: Procedure: Inguinal hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic postoperative pain
Score of 3 or above on the pain domains of the European Registry for Abdominal Wall Hernias Quality of Life (EuraHS QoL) assessment, with higher scores indicating higher pain
Measured: 3 months postoperatively
Secondary outcomes (3)
Proportion of patients receiving antibiotic prophylaxis before inguinal hernia repair
Measured: Intraoperatively
Proportion of patients operated as day case surgery
Measured: 30 days after surgery
Postoperative morbidity
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start7 Oct 2019
- Primary completion12 Jun 2020 (estimated)
- Study completion12 Aug 2020 (estimated)
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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Portuguese Surgical Research Collaborative
- Sponsor type
- Research network
- Collaborators
- University of Lisbon
- Responsible party
- Sponsor
- Investigators
- Antonio Soares, Study chair, Portuguese Surgical Research Collaborative
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328597
- Sponsor's protocol ID
- Version 1
- Acronym
- PINE
- Status last verified
- Mar 2020
- First submitted
- 25 Mar 2020
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans are made to share patient data
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portuguese Inguinal Hernia Cohort Study
- ClinicalTrials.gov ID
- NCT04328597
- Acronym / sponsor ID
- PINE / Version 1
- Conditions
- Inguinal Hernia, Chronic Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Portuguese Surgical Research CollaborativeResearch network
- Collaborators
- University of Lisbon
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 12 Jun 2020 (estimated)
- Study completion
- 12 Aug 2020 (estimated)
- First posted
- 31 Mar 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.
Prospective national cohort study of patients submitted to elective inguinal hernia repair. The primary outcome is the prevalence of chronic postoperative inguinal pain, according to the EuraHS QoL questionnaire at 3 months postoperatively. The study will be delivered in all Portuguese regions through a collaborative research network. Four 2-week inclusion periods will be open for recruitment. A site-specific questionnaire will capture procedure volume and logistical facilities for hernia surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic postoperative pain | – | Procedure: Inguinal hernia repairPatients scoring 3 or more on the EuraHS Quality of Life assessment after elective inguinal hernia repair |
| Non chronic postoperative pain | – | Procedure: Inguinal hernia repairPatients scoring less than 3 on the EuraHS Quality of Life assessment after elective inguinal hernia repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Portuguese patients undergoing inguinal hernia repair in one of the hospitals participating in the study
Key inclusion criteria (2 listed)
- Elective inguinal hernia repair in a portuguese hospital
- Willing and able to consent and comply with the follow up protocol
Key exclusion criteria (1 listed)
- Urgent/emergent inguinal hernia 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 |
|---|---|---|
| Inguinal hernia repairAlso: surgeryInguinal hernia repair (open, laparo-endoscopic, robotic) | Procedure or surgery | Chronic postoperative pain, Non chronic postoperative pain |
Primary outcome
Chronic postoperative pain
Time frame: 3 months postoperatively
Score of 3 or above on the pain domains of the European Registry for Abdominal Wall Hernias Quality of Life (EuraHS QoL) assessment, with higher scores indicating higher pain
3 secondary outcomes
Proportion of patients receiving antibiotic prophylaxis before inguinal hernia repair
Time frame: Intraoperatively
Proportion of patients operated as day case surgery
Time frame: 30 days after surgery
Postoperative morbidity
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: No. No plans are made to share patient data
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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.
Antonio Soares study chair
Portuguese Surgical Research Collaborative
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 Chronic Pain, run by Portuguese Surgical Research Collaborative at 1 site in Portugal.
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 2 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: status not confirmed, as of the sponsor's last update on 1 Apr 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 Portugal. 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?
Results are not available in the source record.
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?
Chronic postoperative pain (time frame: 3 months 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 1 Apr 2020.