Follow-up of Symptomless Inguinal and Ventral Hernias

Laparoscopy Clinical Trial

— hernia  

Official title:

15-year Follow-up of Laparoscopically Diagnosed Occult Inguinal and Ventral Hernias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04683367
• Other study ID #: 139/2020
• Status: Completed
• Phase: N/A
• Start date: January 1, 2003
• Est. completion date: November 30, 2020

Study information

• Verified date: December 2020
• Source: Kuopio University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• occult inguinal or ventral hernia diagnosed in laparoscopic surgery

Exclusion Criteria:

• clinically diagnosed inguinal or ventral hernia

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Hernia, Ventral
• Laparoscopy

Intervention

Procedure:
• laparoscopic surgery
laparoscopic repair of hernia

Locations

Country	Name	City	State
Finland	Kuopio University Hospital	Kuopio

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of operated hernia	occult hernia operated because of symptoms	15 years
Secondary	number of symptomatic hernia	incipient, asymptomatic hernia becomes symptomatic during follow-up	15 years