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Inguinal Hernia Operation and Postoperative Pain

Primary Purpose

Pain, Postoperative, Inguinal Hernia, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Adhesix mesh
Progrip mesh
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University hospital, Jorvi hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group1: Adhesix

Group 2: Progrip

Arm Description

This group gets the Adhesix mesh in a normal open hernia operation.

This group gets the Progrip mesh in a normal open hernia operation.

Outcomes

Primary Outcome Measures

Number of contacts due to postoperative pain
Number of postoperative contacts to the operating unit due to pain at 3 months after the operation

Secondary Outcome Measures

The use of pain medication
The use of painkillers postoperatively
Pain intensity
The 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 contacts
Number of contacts to the operating unit/health care system due to pain after the operation

Full Information

First Posted
October 27, 2018
Last Updated
April 29, 2022
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03734224
Brief Title
Inguinal Hernia Operation and Postoperative Pain
Official Title
Inguinal Hernia Operation and Postoperative Pain - a Prospective and Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Inguinal Hernia, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group1: Adhesix
Arm Type
Active Comparator
Arm Description
This group gets the Adhesix mesh in a normal open hernia operation.
Arm Title
Group 2: Progrip
Arm Type
Active Comparator
Arm Description
This group gets the Progrip mesh in a normal open hernia operation.
Intervention Type
Procedure
Intervention Name(s)
Adhesix mesh
Intervention Description
Adhesix mesh
Intervention Type
Procedure
Intervention Name(s)
Progrip mesh
Intervention Description
Progrip mesh
Primary Outcome Measure Information:
Title
Number of contacts due to postoperative pain
Description
Number of postoperative contacts to the operating unit due to pain at 3 months after the operation
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The use of pain medication
Description
The use of painkillers postoperatively
Time Frame
1 year
Title
Pain intensity
Description
The 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")
Time Frame
1 year
Title
Number of contacts
Description
Number of contacts to the operating unit/health care system due to pain after the operation
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Helsinki University hospital, Jorvi hospital
City
Espoo
Country
Finland

12. IPD Sharing Statement

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Inguinal Hernia Operation and Postoperative Pain

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