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Inguinal Hernia Operation and Postoperative Pain

Inguinal Hernia Operation and Postoperative Pain - a Prospective and Randomized Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03734224
Enrollment
270
Registered
2018-11-07
Start date
2018-11-01
Completion date
2022-04-01
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia, Pain, Postoperative, Quality of Life

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.

Interventions

PROCEDUREAdhesix mesh

Adhesix mesh

PROCEDUREProgrip mesh

Progrip mesh

Sponsors

Helsinki University Central Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 18-80 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Number of contacts due to postoperative pain3 monthsNumber of postoperative contacts to the operating unit due to pain at 3 months after the operation

Secondary

MeasureTime frameDescription
Pain intensity1 yearThe pain intensity at the Numeric Pain Rating Scale (NPRS), where the 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine)
Number of contacts1 yearNumber of contacts to the operating unit/health care system due to pain after the operation
The use of pain medication1 yearThe use of painkillers postoperatively

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026