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Completed

NCT Number: NCT04683367

Follow-up of Symptomless 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.

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Key information

Conditions

Hernia, Inguinal HERNIA, VENTRAL Hernia Hernia, Abdominal Laparoscopy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kuopio University Hospital

Kuopio, 70600, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • occult inguinal or ventral hernia diagnosed in laparoscopic surgery

Exclusion criteria

  • clinically diagnosed inguinal or ventral hernia

Treatment and study plan

Laparoscopic surgery

Procedure

laparoscopic repair of hernia

Other names: hernioplasty

Primary outcomes

  1. number of operated hernia

    Time frame: 15 years

    occult hernia operated because of symptoms

Secondary outcomes

  1. number of symptomatic hernia

    Time frame: 15 years

    incipient, asymptomatic hernia becomes symptomatic during follow-up

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Official study title

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

Acronym: hernia

Important dates

Study start
2003
Primary completion
2020
Study completion
2020
First posted
Dec 24, 2020
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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