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Objective and Perceived Quality Study in Patients Undergoing Elective Groin Hernia Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03860285
Recruitment Status : Active, not recruiting
First Posted : March 1, 2019
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Gorka Docio, Hospital of Navarra

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Inguinal Hernia Quality of Life Surgery Survey Other: Short form 36 quality of life survey

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 850 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
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
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Groups and Cohorts
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Intervention Details:
  • Other: Short form 36 quality of life survey
    Prospective non-comparative observational study of cohorts
    Other Name: European Hernia Society Survey

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Knowing patients' pain [ Time Frame: 4 years ]
    Level of pain, before and after surgery

  2. Registering hernia recurrence [ Time Frame: 4 years ]
    Percentage of patients with hernia recurrence during study surveillance

  3. Controlling presence or not of complications [ Time Frame: 4 years ]
    Presence or not of postop complicationes

  4. Knowing patient satisfaction [ Time Frame: 4 years ]
    Grade of patient satisfaction with surgery result

  5. Knowing duration of sick leave [ Time Frame: 4 years ]
    How long is sick leave

  6. Knowing waiting time for surgery [ Time Frame: 4 years ]
    Patient waiting time until surgery date


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undergoing elective inguinal hernia surgery en Pamplona
Criteria

Inclusion Criteria:

  • Patients entering surgical waiting list during a year (from March 1st, 2018, to February 28th, 2019).
  • Elective surgery.

Exclusion Criteria:

  • Age below 16.
  • Mental diseases.
  • Patients not capable of understanding the study.
  • Patients that reject entering the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860285


Locations
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Spain
Hospital de navarra
Pamplona, Navarra, Spain, 31003
Sponsors and Collaborators
Hospital of Navarra
Investigators
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Study Director: Concepción Yárnoz-Irazabal, PhD Hospital de Navarra
More Information
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Additional Information:

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Responsible Party: Gorka Docio, General Surgeon, Senior, Hospital of Navarra
ClinicalTrials.gov Identifier: NCT03860285    
Other Study ID Numbers: HNavarra
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gorka Docio, Hospital of Navarra:
inguinal hernia
quality of life
survey
surgery
 pamplona
prospective
observational
cohorts
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal