Follow-up of Symptomless Inguinal and Ventral Hernias

Overview

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.

Full Title of Study: “15-year Follow-up of Laparoscopically Diagnosed Occult Inguinal and Ventral Hernias”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 30, 2020

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.

Interventions

  • Procedure: laparoscopic surgery
    • laparoscopic repair of hernia

Arms, Groups and Cohorts

  • Experimental: clinical hernia
    • developing clinical hernia

Clinical Trial Outcome Measures

Primary Measures

  • number of operated hernia
    • Time Frame: 15 years
    • occult hernia operated because of symptoms

Secondary Measures

  • number of symptomatic hernia
    • Time Frame: 15 years
    • incipient, asymptomatic hernia becomes symptomatic during follow-up

Participating in This Clinical Trial

Inclusion Criteria

  • occult inguinal or ventral hernia diagnosed in laparoscopic surgery Exclusion Criteria:

  • clinically diagnosed inguinal or ventral hernia

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kuopio University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hannu Paajanen, Professor of Surgery – Kuopio University Hospital
  • Overall Official(s)
    • Hannu EK Paajanen, MD, PhD, Principal Investigator, department of Surgery, Kuopio Univ Hospital

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