Inguinal Hernia Treatment: Stationary/Inpatient vs. Ambulatory/Outpatient Setting - HerStAmb Study
1 other identifier
observational
237
1 country
1
Brief Summary
Since 01/2018, AVOS (ambulant vor stationär = ambulatory to stationary) regulation has been progressively implemented in hospitals across Switzerland for certain surgical procedures, including the treatment of inguinal hernias. The aim of this prospective, non-randomized, multicenter study was to compare the outcome of outpatient/ambulatory and inpatient/stationary postoperative care by examining the re-admission rate, complication rate and quality of life in patients with primary unilateral inguinal hernia repair.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 1, 2022
CompletedFirst Posted
Study publicly available on registry
February 10, 2022
CompletedFebruary 10, 2022
February 1, 2022
1.2 years
February 1, 2022
February 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
re-admission rate
6 weeks
complication rate
a: seroma, b: hematoma, c: wound infection/dehiscence, d: recurrence, e: pain, f: postop. delirium
6 weeks
quality of life
SF-36 questionnaire
6 weeks
Study Arms (2)
stationary/inpatient
ambulatory/outpatient
Interventions
inguinal hernia repair performed either in stationary/inpatient or ambulatory/outpatient setting
Eligibility Criteria
All the patients included in the study were diagnosed with the symptomatic primary unilateral inguinal hernia. They have various jobs and different lifestyles.
You may qualify if:
- Primary unilateral inguinal hernia
- Written informed consent after participants' information,
- Outpatient or inpatient treatment
You may not qualify if:
- Recurrent hernia
- Bilateral hernia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr. Michal Zigalead
Study Sites (1)
Cantonal Hospital Schaffhausen
Schaffhausen, Switzerland
Related Publications (1)
Ziga M, Burla L, Imhof A, Gurtler T, Weber M. Inguinal hernia treatment in Switzerland: inpatient vs. outpatient setting - HerStAmb Study (prospective observational two-centre comparative study). Langenbecks Arch Surg. 2023 Jan 9;408(1):14. doi: 10.1007/s00423-023-02766-y.
PMID: 36622458DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Michal Ziga, Dr.
Cantonal Hospital Schaffhausen
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
February 1, 2022
First Posted
February 10, 2022
Study Start
January 1, 2019
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
February 10, 2022
Record last verified: 2022-02