Laparoscopic High-Ligation Repair of Indirect Inguinal Hernias in Adults

NCT06120114 | Completed

• 1 other identifier: 2015/1053(REK)
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Inguinal hernia surgery has undergone significant and extensive transformation, including the advent of tissue-based repairs and later, tension-free repairs with the acceptance of prosthetic mesh. However, there is still significant pain associated with the use of mesh, as well as the risk of potential injury to neurovascular structures. In the pediatric population, non-mesh laparoscopic high-ligation repair of indirect inguinal hernias is one of the most common procedures performed. High-ligation of indirect inguinal hernias in the adolescent population is also effective, with a low recurrence rate and low incidence of chronic symptoms, but this technique is uncommonly used by adult hernia surgeons due to concern for recurrence.The purpose of this study is to conduct a pilot trial to examine the efficacy of high-ligation repair of indirect inguinal hernias in adult patients. Our hypothesis is that the laparoscopic, non-mesh repair technique is an effective method of repairing indirect inguinal hernias, with an acceptable recurrence rate and decreased postoperative pain. This pilot trial will allow the design of a randomized clinical trial comparing the efficacy of this technique to other standard repair techniques.

Conditions

Inguinal Hernia, Indirect; Surgery; Postoperative Pain; Recurrence

Keywords

Laparoscopy; Inguinal; Hernia; Indirect

Outcome Measures

Primary Outcomes (1)

• Number of patients with inguinal hernia recurrence

  Number of patients with recurrence determined by clinical examination

  One month and one year after surgery

Secondary Outcomes (3)

• Degree of pain related to the hernia or hernia surgery

  Prior to surgery and one month and one year after surgery

• Health related quality of life

  Prior to surgery and one month and one year after surgery

• physical activity levels assessed by scale

  Prior to surgery and one month and one year after surgery

Other Outcomes (1)

• Number of patients with self-reported inguinal hernia recurrence

  Through study completion, a median of 89 months

Study Arms (1)

Modified percutaneous internal ring suturing

EXPERIMENTAL

Patients with indirect inguinal hernia operated with modified percutaneous internal ring suturing

Procedure: Modified percutaneous internal ring suturing

Interventions

Modified percutaneous internal ring suturing PROCEDURE

Laparoscopically guided percutaneous high ligation of indirect inguinal hernia in adults

Also known as: PIRS

Modified percutaneous internal ring suturing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who present to the office of the study investigators for repair of an indirect inguinal hernia

You may not qualify if:

• Recurrent hernia
• Emergent cases
• Cirrhosis or liver disease (bilirubin \> 3 mg/dL).
• Subjects on dialysis
• Subjects with collagen vascular disease
• BMI over 35 kg/m2
• Bilateral inguinal hernias
• Direct inguinal hernia

Sponsors & Collaborators

• University Hospital of North Norway: lead

MeSH Terms

Conditions

Hernia, Inguinal; Pain, Postoperative; Recurrence; Hernia

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms; Disease Attributes

Study Officials

• Rolv-Ole Lindsetmo

  University Hospital North Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD, Consultant Surgeon

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 7, 2023
• Study Start: June 20, 2015
• Primary Completion: November 7, 2020
• Study Completion: October 7, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share