Follow-up of Symptomless Inguinal and Ventral Hernias (hernia)

• ClinicalTrials.gov Identifier: NCT04683367
• Recruitment Status: Completed
• First Posted: December 24, 2020
• Last Update Posted: December 24, 2020
• Sponsor: Kuopio University Hospital
• Information provided by (Responsible Party): Hannu Paajanen, Kuopio University Hospital

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.

Condition or disease	Intervention/treatment	Phase
Hernia, Inguinal; Hernia, Ventral; Laparoscopy	Procedure: laparoscopic surgery	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 201 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 15-year Follow-up of Laparoscopically Diagnosed Occult Inguinal and Ventral Hernias
• Actual Study Start Date: January 1, 2003
• Actual Primary Completion Date: November 30, 2020
• Actual Study Completion Date: November 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: clinical hernia; developing clinical hernia	Procedure: laparoscopic surgery; laparoscopic repair of hernia; Other Name: hernioplasty

Outcome Measures

Primary Outcome Measures :

1. number of operated hernia [ Time Frame: 15 years ]
   occult hernia operated because of symptoms

Secondary Outcome Measures :

1. number of symptomatic hernia [ Time Frame: 15 years ]
   incipient, asymptomatic hernia becomes symptomatic during follow-up

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• occult inguinal or ventral hernia diagnosed in laparoscopic surgery

Exclusion Criteria:

• clinically diagnosed inguinal or ventral hernia

Contacts and Locations

Locations

Finland

Kuopio University Hospital

Kuopio, Finland, 70600

Sponsors and Collaborators

Kuopio University Hospital

Investigators

• Principal Investigator: Hannu EK Paajanen, MD, PhD; department of Surgery, Kuopio Univ Hospital

More Information

• Responsible Party: Hannu Paajanen, Professor of Surgery, Kuopio University Hospital
• ClinicalTrials.gov Identifier: NCT04683367
• Other Study ID Numbers: 139/2020
• First Posted: December 24, 2020
• Last Update Posted: December 24, 2020
• Last Verified: December 2020

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

Keywords provided by Hannu Paajanen, Kuopio University Hospital:

inguinal hernia; ventral hernia; laparoscopic diagnosis

Additional relevant MeSH terms:

Hernia; Hernia, Ventral; Hernia, Inguinal; Pathological Conditions, Anatomical; Hernia, Abdominal