Inguinal HerniaNCT03860285
Objective and Perceived Quality Study in Patients Undergoing Elective Groin Hernia Surgery
An observational study of Inguinal Hernia and Quality of Life, run by Hospital of Navarra at 1 site in Spain.
Trial summary
This is a prospective non-comparative observational study of cohorts. Consists on offering surveys to every patient undergoing groin hernia surgery in our Abdominal Wall Surgery Unit, in Hospital of Navarra. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia, Quality of Life, Surgery
- What is being tested?
- Short form 36 quality of life survey
- How many people
- 850 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2018to 31 Dec 2023
- How long will I take part?
- 4 Years
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients undergoing elective inguinal hernia surgery en Pamplona
Who may be able to join
- Patients entering surgical waiting list during a year (from March 1st, 2018, to February 28th, 2019).
- Elective surgery.
Who cannot join
- Age below 16.
- Mental diseases.
- Patients not capable of understanding the study.
- Patients that reject entering the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Objective and Perceived Quality Study in Patients Undergoing Elective Groin Hernia Surgery by the Abdominal Wall Surgery Unit of the Hospital Complex of Navarra
This is a prospective non-comparative observational study of cohorts. Consists on offering surveys to every patient undergoing groin hernia surgery in our Abdominal Wall Surgery Unit, in Hospital of Navarra.
Read the detailed description
HYPOTHESIS:
The objective and perceived quality data of the patients under study (adult patients undergoing scheduled inguinal hernia without complications) in Pamplona are within the international quality standards.
OBJECTIVES
Primary objective:
-Obtaining data of objective and perceived quality of patients undergoing elective groin hernia surgery in Pamplona durinag a year to compare them with international quality standards.
Secondary objectives:
- Obtaining data on duration of sick leave (temporary disability due to common contingency) associated with the referred procedures, as well as their possible complications.
- Assess the costs associated with the intervention and its possible complications.
- Raise options (if necessary and feasible) to improve the results exposed obtained by our service.
- Conditions
- Inguinal Hernia, Quality of Life, Surgery, Survey
- Being tested
- Short form 36 quality of life survey
- Keywords
- inguinal hernia, quality of life, survey, surgery, pamplona, prospective, observational, cohorts
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short form 36 quality of life surveyOther
Also called European Hernia Society Survey
Prospective non-comparative observational study of cohorts
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtaining objective and perceived quality of life
Obtaining data about objective and perceived quality of life of patients undergoing elective inguinal hernia surgery in Pamplona during a year to compare them with international quality standards
Measured: 4 years
Secondary outcomes (6)
Knowing patients' pain
Level of pain, before and after surgery
Measured: 4 years
Registering hernia recurrence
Percentage of patients with hernia recurrence during study surveillance
Measured: 4 years
Controlling presence or not of complications
Presence or not of postop complicationes
Measured: 4 years
Knowing patient satisfaction
Grade of patient satisfaction with surgery result
Measured: 4 years
Knowing duration of sick leave
How long is sick leave
Measured: 4 years
Knowing waiting time for surgery
Patient waiting time until surgery date
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start1 Mar 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: Pending changes in recruitment
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
- 850 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Hospital of Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gorka Docio, Hospital of Navarra
- Investigators
- Concepción Yárnoz-Irazabal, PhD, Study director, Hospital de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03860285
- Sponsor's protocol ID
- HNavarra
- Status last verified
- Mar 2023
- First submitted
- 2 Dec 2018
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective and Perceived Quality Study in Patients Undergoing Elective Groin Hernia Surgery by the Abdominal Wall Surgery Unit of the Hospital Complex of Navarra
- ClinicalTrials.gov ID
- NCT03860285
- Acronym / sponsor ID
- HNavarra
- Conditions
- Inguinal Hernia, Quality of Life, Surgery, Survey
- Keywords
- inguinal hernia, quality of life, survey, surgery, pamplona, prospective, observational, cohorts
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Pending changes in recruitment
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Hospital of NavarraUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Mar 2019 (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.
This is a prospective non-comparative observational study of cohorts. Consists on offering surveys to every patient undergoing groin hernia surgery in our Abdominal Wall Surgery Unit, in Hospital of Navarra.
Detailed description
HYPOTHESIS:
The objective and perceived quality data of the patients under study (adult patients undergoing scheduled inguinal hernia without complications) in Pamplona are within the international quality standards.
OBJECTIVES
Primary objective:
-Obtaining data of objective and perceived quality of patients undergoing elective groin hernia surgery in Pamplona durinag a year to compare them with international quality standards.
Secondary objectives:
- Obtaining data on duration of sick leave (temporary disability due to common contingency) associated with the referred procedures, as well as their possible complications.
- Assess the costs associated with the intervention and its possible complications.
- Raise options (if necessary and feasible) to improve the results exposed obtained by our service.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing elective inguinal hernia surgery en Pamplona
Key inclusion criteria (2 listed)
- Patients entering surgical waiting list during a year (from March 1st, 2018, to February 28th, 2019).
- Elective surgery.
Key exclusion criteria (4 listed)
- Age below 16.
- Mental diseases.
- Patients not capable of understanding the study.
- Patients that reject entering the study.
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 |
|---|---|---|
| Short form 36 quality of life surveyAlso: European Hernia Society SurveyProspective non-comparative observational study of cohorts | Other | – |
Primary outcome
Obtaining objective and perceived quality of life
Time frame: 4 years
Obtaining data about objective and perceived quality of life of patients undergoing elective inguinal hernia surgery in Pamplona during a year to compare them with international quality standards
6 secondary outcomes
Knowing patients' pain
Time frame: 4 years
Registering hernia recurrence
Time frame: 4 years
Controlling presence or not of complications
Time frame: 4 years
Knowing patient satisfaction
Time frame: 4 years
Knowing duration of sick leave
Time frame: 4 years
Knowing waiting time for surgery
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Concepción Yárnoz-Irazabal, PhD study director
Hospital de Navarra
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 Quality of Life, run by Hospital of Navarra 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 2 inclusion and 4 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: paused, as of the sponsor's last update on 14 Mar 2023. 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?
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?
Obtaining objective and perceived quality of life (time frame: 4 years). 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 Mar 2023.