Comparison of Laparoscopic and Open Inguinal Hernia Repair in Elderly Patients

May 11, 2024 updated by: Mehmet Eşref Ulutaş
Inguinal hernia is one of the most frequently performed surgeries in general surgery. This surgery can be performed with both open and laparoscopic techniques. There is no clear consensus on whether inguinal hernia repair, which is one of the most frequently performed surgeries in elderly patients, should be performed open or laparoscopic. The application of the open technique with regional anesthesia methods such as spinal anesthesia and local anesthesia makes these methods attractive. The fact that laparoscopic techniques cause patients to recover faster also makes these techniques attractive. However, the fact that it is usually performed under general anesthesia is a significant disadvantage. Increasing comorbidities and increased drug use, especially in elderly patients, make surgeons think about which technique to prefer. The aim of this study is to compare open and laparoscopic inguinal hernia repair, which should be preferred in patients over 65 years of age.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Van, Turkey
        • Recruiting
        • University of Health Science Van Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with inguinal hernias.
  • Patients aged over 65.

Exclusion Criteria:

  • Younger than 65 years.
  • Incarcerated or strangulated inguinal hernias.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laparoscopic TEP Repair under General Anesthesia
A mini-incision was made at the umbilical margin, passing through the skin and subcutaneous tissue to expose the external sheath of the rectus muscle. The RS was incised, and the rectus muscle was laterally displaced. A 10-mm trocar was inserted into the preperitoneal space, and CO2 insufflation was performed with a pressure set at 12 mmHg. Two additional 5 mm trocars were inserted between the umbilicus and the symphysis pubis under laparoscopic guidance. Using laparoscopic dissectors and graspers, all steps of myopectineal orifice dissection were performed (16). A 15 × 10 cm prolene mesh was spread and secured to cover both direct and indirect hernia areas, extending approximately 2-3 cm beyond. Trocars were removed under camera surveillance after CO2 desufflation, and the skin was closed.
Procedure: Laparoscopic TEP Repair
Laparoscopic TEP Repair performed
Active Comparator: Open Technique (Lichtenstein) under Spinal Anesthesia
Following a classic inguinal incision of approximately 5-7 cm extending laterally from the pubic tubercle, the external oblique aponeurosis was opened, the external ring was disrupted, and the spermatic cord/round ligament was suspended. The hernia sac was isolated from surrounding tissues and the spermatic cord/round ligament, then either reduced or ligated. Subsequently, a polypropylene mesh measuring approximately 60x110 mm² was placed to completely cover the transverse fascia, and continuous sutures were used to secure it laterally along the transverse arch starting from the pubic tubercle. Hemostasis was achieved, and the layers and skin were anatomically closed.
Procedure: Open Technique (Lichtenstein)
Open Technique (Lichtenstein) performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of postoperative mortality
Time Frame: postoperative 24 hours
postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Postoperative complications
Time Frame: postoperative 24 hours and 1st month
such as wound infection, bleeding
postoperative 24 hours and 1st month
rate of urinary retansion
Time Frame: postoperative 24 hours
postoperative 24 hours
rate of postoperative pain
Time Frame: postoperative 24 hours
postoperative 24 hours
Rate of Hernia recurrence
Time Frame: first year
first year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mehmet Eşref Ulutaş

Collaborators

Van Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2023

Primary Completion (Estimated)

June 4, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

May 11, 2024

First Submitted That Met QC Criteria

May 11, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 65646564

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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