Inguinal Hernia Operation and Postoperative Pain
1 other identifier
interventional
270
1 country
1
Brief Summary
Inguinal hernia is a common disease, which is treated surgically when symptomatic. Pain after open inguinal hernia surgery can affect the patient significantly and weaken their quality of life. The aim of this study is to find out if the choice of mesh affects postoperative pain and therefore causes more contacts to the health care center. Our goal is also to find out how the pain affects the patients´ quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2018
CompletedStudy Start
First participant enrolled
November 1, 2018
CompletedFirst Posted
Study publicly available on registry
November 7, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedMay 2, 2022
April 1, 2022
3.4 years
October 27, 2018
April 29, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Number of contacts due to postoperative pain
Number of postoperative contacts to the operating unit due to pain at 3 months after the operation
3 months
Secondary Outcomes (3)
The use of pain medication
1 year
Pain intensity
1 year
Number of contacts
1 year
Study Arms (2)
Group1: Adhesix
ACTIVE COMPARATORThis group gets the Adhesix mesh in a normal open hernia operation.
Group 2: Progrip
ACTIVE COMPARATORThis group gets the Progrip mesh in a normal open hernia operation.
Interventions
Eligibility Criteria
You may qualify if:
- years old male patients, with a symptomatic inguinal hernia that can be diagnosed by clinical examination. Primary and unilateral hernia. The operation performed at a day surgery unit.
You may not qualify if:
- female
- bilateral hernia
- Incarcerated hernia
- Scrotal hernia
- ASA-classification \>3
- BMI \>35 or \<18
- No hernia found in clinical examination
- Liver cirrhosis
- Other contraindication for inguinal hernia operation
- Anticoagulant therapy, that needs bridge therapy when paused
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Helsinki University hospital, Jorvi hospital
Espoo, Finland
Related Publications (1)
Tholix AM, Kossi J, Harju J. One-year outcome after open inguinal hernia repair with self-fixated mesh: a randomized controlled trial. Langenbecks Arch Surg. 2023 Sep 21;408(1):369. doi: 10.1007/s00423-023-03106-w.
PMID: 37733083DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Surgical resident
Study Record Dates
First Submitted
October 27, 2018
First Posted
November 7, 2018
Study Start
November 1, 2018
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
May 2, 2022
Record last verified: 2022-04