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

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.

Study Overview

• Status: Suspended
• Conditions: Quality of Life; Inguinal Hernia; Surgery; Survey
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 850

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31003
      • Hospital de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients undergoing elective inguinal hernia surgery en Pamplona

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital of Navarra
• Investigators: Study Director: Concepción Yárnoz-Irazabal, PhD, Hospital de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: December 2, 2018
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; surgery; prospective; survey; observational; inguinal hernia; cohorts; pamplona
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: HNavarra

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No