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

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03860285
• Other study ID #: HNavarra
• Status: Suspended
• Start date: March 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Hospital of Navarra
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Quality of Life
• Surgery
• Survey

Intervention

Other:
• Short form 36 quality of life survey
Prospective non-comparative observational study of cohorts

Locations

Country	Name	City	State
Spain	Hospital de navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Hospital of Navarra

Country where clinical trial is conducted

Spain, 

Outcome

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