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

Suspended

• Conditions: Surgery; Inguinal Hernia; Quality of Life; Survey

• Registration Number: NCT03860285
• Lead Sponsor: Hospital of Navarra

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.

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 Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-12-02
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-12
• Last Update Posted: 2023-03-14
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 850

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obtaining objective and perceived quality of life	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

Name	Time	Method
Registering hernia recurrence	4 years	Percentage of patients with hernia recurrence during study surveillance
Knowing patients' pain	4 years	Level of pain, before and after surgery
Knowing duration of sick leave	4 years	How long is sick leave
Knowing waiting time for surgery	4 years	Patient waiting time until surgery date
Controlling presence or not of complications	4 years	Presence or not of postop complicationes
Knowing patient satisfaction	4 years	Grade of patient satisfaction with surgery result

Trial Locations

Locations (1)

Hospital de navarra; 🇪🇸 Pamplona, Navarra, Spain