Quality of Life Clinical Trial
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
NCT number | NCT03860285 |
Other study ID # | HNavarra |
Secondary ID | |
Status | Suspended |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2018 |
Est. completion date | December 31, 2023 |
Verified date | March 2023 |
Source | Hospital of Navarra |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Suspended |
Enrollment | 850 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital de navarra | Pamplona | Navarra |
Lead Sponsor | Collaborator |
---|---|
Hospital of Navarra |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 4 years | |
Secondary | Knowing patients' pain | Level of pain, before and after surgery | 4 years | |
Secondary | Registering hernia recurrence | Percentage of patients with hernia recurrence during study surveillance | 4 years | |
Secondary | Controlling presence or not of complications | Presence or not of postop complicationes | 4 years | |
Secondary | Knowing patient satisfaction | Grade of patient satisfaction with surgery result | 4 years | |
Secondary | Knowing duration of sick leave | How long is sick leave | 4 years | |
Secondary | Knowing waiting time for surgery | Patient waiting time until surgery date | 4 years |
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