Study on Effects of Defect Closure in Laparoscopic Repair of Direct Inguinal Hernia

August 10, 2024 updated by: Vijay Pratap Sah, B.P. Koirala Institute of Health Sciences

A Comparative Study on Effects of Defect Closure Versus Non-Closure in Laparoscopic Totally Extraperitoneal Repair of Direct Inguinal Hernia

The defect closure was found to have higher pain and less seroma formation at various intervals of time following TEP for moderate-large direct inguinal hernia. Although these findings were statistically insignificant, they may be clinically significant, and further studies with a larger sample size are suggested.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inguinal hernia is a common and widespread condition from which millions of people suffer. Repair of an inguinal hernia is one of the most frequently performed operations in general surgery. Totally extraperitoneal (TEP) and transabdominal preperitoneal (TAPP) repair are the principal techniques in laparoscopic hernia repair. Laparoscopic hernia repair is recommended for bilateral and recurrent inguinal hernias. It has also been recommended for patients with primary unilateral inguinal hernia, contingent on the availability of surgical expertise and resources, due to a lower incidence of post-operative pain and chronic pain.

Seroma formation is a frequent complication of laparoscopic mesh repair of moderate-large direct inguinal hernia defects. While rates of seroma formation have been reported to be as high as 10-30%. Several attempts have been made to reduce the incidence of seroma formation, such as tacking the transversalis fascia (TF) to the ramus of the pubis, closing the direct inguinal hernia defect via the endoloop technique, and filling the potential dead space with fibrin glue. However, there is a potential increase in the risk of infection and also a risk of chronic pubic bone pain from the tack staples or vasculo-nervous injury if fixing the TF to the abdominal wall, which would lead to extra discomfort for the patient. The closure of a direct hernia defect with a barbed suture not only closes the defect superficially but also exterminates the defect cavity; consequently, the incidence of seroma formation has been greatly reduced.

However, there is still controversial evidence regarding the choice of the two procedures in terms of reducing the rate of seroma formation and pain. Thus, it is ambiguous which surgical technique should be considered best to repair an inguinal hernia. In this study, we tried to evaluate the technical aspect of direct defect closure in laparoscopic TEP inguinal hernia repair and its effect on the primary outcomes in terms of seroma formation and pain at different time intervals, along with the secondary outcomes such as operative time, length of postoperative hospital stay, days to resume normal activities, recurrence, and intraoperative complications like injury to the vas, vessel, and visceral injury or peritoneal tear.

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

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

Study Locations

  • Nepal
    • Madhesh Pradesh
      • Malangwa, Madhesh Pradesh, Nepal
        • Vijay Pratap Sah

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with inguinal hernia presenting to surgery OPD

Description

Inclusion Criteria:

  • age greater than 18 years
  • uncomplicated direct inguinal hernia (≥M3)

Exclusion Criteria:

  • defect size ≤M2
  • complicated hernia (irreducible, obstructed, or recurrent hernia)
  • patients unfit for general anesthesia

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
defect closure
the fascia transversalis (pseudo sac) was pulled and incorporated into closure with a non-absorbable polypropylene barbed monofilament size-0 suture
Other: closed the defect with barbed suture
In direct hernia, content was reduced, and the fascia transversalis (pseudo sac) was pulled and incorporated into closure with a non-absorbable polypropylene barbed monofilament size-0 suture
non closure group
defect was left open

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
seroma formation in defect closure group
Time Frame: till 6 months
After closing the defect, there is less seroma formation than in the defect non closure group
till 6 months

Collaborators and Investigators

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

Sponsor

B.P. Koirala Institute of Health Sciences

Investigators

  • Principal Investigator: Rakesh Kumar Gupta, MS, B. P. Koirala Institute of Health Science

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)

September 1, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

April 24, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 10, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRC/1971/020

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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