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

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

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.

Study Overview

• Status: Completed
• Conditions: Hernia, Inguinal; Hernia, Ventral; Laparoscopy
• Intervention / Treatment: Procedure: laparoscopic surgery

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 Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland, 70600
    • Kuopio University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• occult inguinal or ventral hernia diagnosed in laparoscopic surgery

Exclusion Criteria:

• clinically diagnosed inguinal or ventral hernia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: clinical hernia; developing clinical hernia	Procedure: laparoscopic surgery; laparoscopic repair of hernia; Other Names: hernioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of operated hernia	occult hernia operated because of symptoms	15 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of symptomatic hernia	incipient, asymptomatic hernia becomes symptomatic during follow-up	15 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2003
• Primary Completion (ACTUAL): November 30, 2020
• Study Completion (ACTUAL): November 30, 2020

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (ACTUAL): December 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 24, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: ventral hernia; inguinal hernia; laparoscopic diagnosis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Hernia, Ventral
• Other Study ID Numbers: 139/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No