Follow-up of Symptomless Inguinal and Ventral Hernias (hernia)
Primary Purpose
Hernia, Inguinal, Hernia, Ventral, Laparoscopy
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
laparoscopic surgery
Sponsored by
About this trial
This is an interventional diagnostic trial for Hernia, Inguinal focused on measuring inguinal hernia, ventral hernia, laparoscopic diagnosis
Eligibility Criteria
Inclusion Criteria:
- occult inguinal or ventral hernia diagnosed in laparoscopic surgery
Exclusion Criteria:
- clinically diagnosed inguinal or ventral hernia
Sites / Locations
- Kuopio University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
clinical hernia
Arm Description
developing clinical hernia
Outcomes
Primary Outcome Measures
number of operated hernia
occult hernia operated because of symptoms
Secondary Outcome Measures
number of symptomatic hernia
incipient, asymptomatic hernia becomes symptomatic during follow-up
Full Information
NCT ID
NCT04683367
First Posted
December 16, 2020
Last Updated
December 21, 2020
Sponsor
Kuopio University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04683367
Brief Title
Follow-up of Symptomless Inguinal and Ventral Hernias
Acronym
hernia
Official Title
15-year Follow-up of Laparoscopically Diagnosed Occult Inguinal and Ventral Hernias
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2003 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The orifices of all inguinal and ventral (including Spigelian) hernias were carefully recorded at the beginning of laparoscopy (n=201) of other reason (cholecystectomy, fundoplication) in 2003-5. The patients with occult hernias (n=43) were followed-up 15 years to find out what percentage of hernias would become symptomatic.
Detailed Description
This was a prospective laparoscopic study of 201 consecutive adult patients operated in 2003-5. There were 133 females and 68 males with a mean age 53 ± 14 years. The index laparoscopic operation included 104 cholecystectomies, 55 fundoplications, 36 diagnostic, 5 appendectomies and one insertion of peritoneal catheter. A careful clinical examination of the groin and ventral region was performed on everybody and all patients with clinical hernias were excluded. Laparoscopic exploration of the inguinal region was considered safe and did not greatly increase the operative time. All patients were informed that hernial orifices would be explored during laparoscopy, and a written consent was asked prior to surgery. Permission to repair large hernias (> 1 cm) was also obtained before laparoscopy.
The patients were followed-up 15 years to find out, what percentage of occult, symptomless inguinal and ventral hernias were later operated because of harmfull symptoms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal, Hernia, Ventral, Laparoscopy
Keywords
inguinal hernia, ventral hernia, laparoscopic diagnosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
201 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clinical hernia
Arm Type
Experimental
Arm Description
developing clinical hernia
Intervention Type
Procedure
Intervention Name(s)
laparoscopic surgery
Other Intervention Name(s)
hernioplasty
Intervention Description
laparoscopic repair of hernia
Primary Outcome Measure Information:
Title
number of operated hernia
Description
occult hernia operated because of symptoms
Time Frame
15 years
Secondary Outcome Measure Information:
Title
number of symptomatic hernia
Description
incipient, asymptomatic hernia becomes symptomatic during follow-up
Time Frame
15 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
occult inguinal or ventral hernia diagnosed in laparoscopic surgery
Exclusion Criteria:
clinically diagnosed inguinal or ventral hernia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannu EK Paajanen, MD, PhD
Organizational Affiliation
department of Surgery, Kuopio Univ Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70600
Country
Finland
12. IPD Sharing Statement
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Follow-up of Symptomless Inguinal and Ventral Hernias
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