Follow-up of Symptomless Inguinal and Ventral Hernias

NCT ID: NCT04683367

Last Updated: 2020-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-01-01
• Study Completion Date: 2020-11-30

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.

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.

Conditions

Hernia, Inguinal; Hernia, Ventral; Laparoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

clinical hernia

developing clinical hernia

Group Type: EXPERIMENTAL

laparoscopic surgery

Intervention Type: PROCEDURE

laparoscopic repair of hernia

Interventions

laparoscopic surgery

laparoscopic repair of hernia

Intervention Type: PROCEDURE

Other Intervention Names

hernioplasty

Eligibility Criteria

Inclusion Criteria

• occult inguinal or ventral hernia diagnosed in laparoscopic surgery

Exclusion Criteria

• clinically diagnosed inguinal or ventral hernia

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kuopio University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hannu Paajanen

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hannu EK Paajanen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

department of Surgery, Kuopio Univ Hospital

Locations

Kuopio University Hospital

Kuopio, , Finland

Countries

Finland

Other Identifiers

139/2020

Identifier Type: -

Identifier Source: org_study_id