Longitudinal Relaxing Incision as a Technique for Recurrence Prevention in Ventral Hernia

August 31, 2022 updated by: Mostafa Hussien Mohamed sabry Hussien, Assiut University

Longitudinal Relaxing Incision as a Technique for Recurrence Prevention in Ventral Hernia... Does it Help?

The aim of the study is showing the efficiency of using Longitudinal relaxing incision as a Technique for recurrence prevention in Ventral Hernia

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Ventral hernias of the abdomen are defined as a non-inguinal, nonhiatal defect in the fascia of the abdominal wall. Annually, there are about 350,000 ventral hernia operations. The repair of these abdominal wall defects is a common surgery performed by general surgeons. Surgery is typically recommended for individuals with acceptable operative risk, symptomatic hernias, or those at elevated risk of developing complications from a hernia. They can affect an individual's quality of life and can lead to hospitalizations and even death in some cases Etiologies of a ventral hernia can be broken down into 2 main categories; acquired or congenital. The vast majority of hernias that general surgeons see and treat are acquired; however, some individuals live with their ventral hernias from birth for prolonged periods of time before having them surgically repaired. Common causes of acquired ventral hernias include previous surgery causing an incisional hernia, trauma, and repetitive stress on naturally weak points of the abdominal wall. These naturally occurring weak points in the abdominal wall include the umbilicus, semilunar line, ostomy sites, bilateral inguinal regions, and esophageal hiatus. Obesity is a large component of hernias as well because it stretches the fascia of the abdomen causing it to weaken. Specifically, the action of repetitive weight gain and loss leads to weakening The most common treatment of ventral hernias includes surgery. Asymptomatic hernias are repaired on an elective basis, but those presenting with strangulation require immediate surgery. Incarceration without strangulation is not a surgical emergency; however, the risks and benefits of surgery should be discussed with the patient, and a patient with reasonable operative risk should have their hernia repaired within a sensible time frame. Non-surgical management of abdominal wall hernias with the use of binders, trusses, or corsets is not considered to be effective. However, this may be the only option in a patient who is not a reasonable candidate for surgery Over the years, many types of surgical techniques have been developed to repair hernias. There are many tenants of hernia repair. The most important being a tension-free closure, but others include the use of a mesh with 3 to 5 cm of overlap, meticulous handling of the mesh, preventing surgical site infections, and using a sublay technique with the closure of the fascia if possible. The most basic approach is a primary open repair without mesh, which should typically be reserved for defects in the fascia of less than 2 cm. An open repair with mesh has several options including what type of mesh and where to place the mesh.

Hernia recurrence is an extremely important postoperative outcome and assesses surgical efficacy. The ability to predict recurrence accurately would have considerable clinical utility, allowing surgeons to make better-informed decisions with their patients as to when and when not, to operate.

Multiple associated conditions, such as obesity, smoking, and others, have been reported in various studies to contribute to higher recurrence rates.

Study Type

Observational

Enrollment (Anticipated)

40

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 Contact Backup

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

cases with Ventral Hernia admitted at Assiut University Hospital at the period of the study

Description

Inclusion Criteria:

  • any patient with Ventral Hernia admitted at Assiut University Hospital

Exclusion Criteria:

  • recurrent hernia
  • complicated [obstructed & strangulated]

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1 with using longitudinal relaxing incision
using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia
Procedure: using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia
using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia
2 without using longitudinal relaxing incision
without using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
longitudinal relaxing incision
Time Frame: baseline
the efficiency of using longitudinal relaxing incision as a technique for recurrence prevention in ventral hernia
baseline

Collaborators and Investigators

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

Sponsor

Assiut University

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 (Anticipated)

September 1, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

August 23, 2022

First Submitted That Met QC Criteria

August 31, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

September 2, 2022

Last Update Submitted That Met QC Criteria

August 31, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ventral Hernia

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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