Postoperative Outcomes of Trans-abdominal Open Surgical Repair of Traumatic Diaphragmatic Hernias in Adults.

October 21, 2022 updated by: Tamer.A.A.M.Habeeb, Zagazig University

Objective: Evaluation of our management of acute or chronic traumatic diaphragmatic hernia repair with sutures or mesh.

Between January 2014 and January 2019, a retrospective study on 185 patients with acute and chronic traumatic diaphragmatic hernias was carried out at the general surgery department of Zagazig University. Results both during and after surgery were assessed.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Traumatic diaphragmatic hernias are the outcome of 0.8% to 6% of blunt trauma cases and more than 17% of cases involving thoraco-abdominal-penetrating trauma (TDH) . Chronic traumatic diaphragmatic herniation (CTDH) is a condition that can develop as a result of an enlargement of a defect in the diaphragm brought on by a pressure difference between the thoracic cavity and the abdominal cavity . It is possible that the rupture will not heal on its own due to the inherent pressure difference that exists between the thorax and the abdomen as well as the continuous movement of the diaphragm .

Due to the seriousness of the related organs' injuries, traumatic diaphragmatic rupture presents a complex emergency and typically necessitates a high diagnostic suspicion. The herniated structures may strangulate into the thoracic cavity, and the mortality rate may increase considerably if the traumatic diaphragmatic hernia is not identified and treated in the acute phase of the trauma . These patients may not be diagnosed until weeks, months, or even years after the initial traumatic event, and they may present with acute symptoms related to the cardiovascular system and the digestive tract. A high mortality rate is seen in people with CTDH with viscera that have been strangulated.

Despite advancements in diagnostic technologies, 2.7 - 50% of patients still have a misdiagnosis . Early, accurate diagnosis is now more common thanks to greater experience and the emergence of imaging tools, particularly computed tomography (CT).

A limited number of researches describe acute and chronic traumatic diaphragmatic hernias in terms of intraoperative and postoperative outcomes. To examine the intraoperative and postoperative results of patients with traumatic diaphragmatic hernias repaired using either suture repair or mesh repair in terms of morbidity, mortality rate, and incidence of recurrence, the investigators have established a retrospective cohort analysis for the current investigation.

Study Type

Observational

Enrollment (Actual)

185

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Between January 2014 and January 2019, 185 patients with acute and chronic traumatic diaphragmatic hernia underwent a retrospective observational study at the general surgery department of Zagazig University. Patients who were >18 years old, male or female, and had an acute or chronic traumatic diaphragmatic hernia met the inclusion criteria. Hiatus hernias, congenital hernias, diaphragmatic tears without herniation of abdominal organs, eventration of the diaphragm, hernias on both sides of the diaphragm, and recurrent diaphragmatic hernia after prior repair were all excluded from the study.

Description

Inclusion Criteria:

  • >18 years old, male or female, and had an acute or chronic traumatic diaphragmatic hernia

Exclusion Criteria:

  • Hiatus hernias, congenital hernias, diaphragmatic tears without herniation of abdominal organs, eventration of the diaphragm, hernias on both sides of the diaphragm, and recurrent diaphragmatic hernia after prior repair

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: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrent hernia
Time Frame: 3.5 years
recurrence of diaphragmatic hernia after repair
3.5 years

Collaborators and Investigators

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

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)

January 1, 2014

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

October 16, 2022

First Submitted That Met QC Criteria

October 21, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Actual)

October 24, 2022

Last Update Submitted That Met QC Criteria

October 21, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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