Stepwise for the Treatment of Lateral Incisional Hernias

January 24, 2022 updated by: Miguel A ngel Garci-a Urena, Henares University Hospital

The best approach for lateral incisional hernia is not known. Posterior component separation (reverse TAR) offers the possibility of using the retromuscular space for medial extension of the challenging preperitoneal plane.

The main objective of the study was to describe the surgical techniques used and their outcomes in the open lateral approach for the treatment of L3-L4 European Hernia Society (EHS) classification Incisional hernias, comparing the results between reverse TAR and pure lateral retromuscular preperitoneal, and analyzing the short- and long- term complications, including patient-reported outcomes measures (PROMs).

The study report followed the recommendations for reporting outcomes in abdominal wall hernias, and the new international classification of abdominal wall planes (ICAP).

A multicenter retrospective observational study was conducted using a prospectively maintained database from three university hospitals in Spain specialized in complex abdominal wall reconstruction. All patients undergoing open abdominal wall repair through the previous lateral incision for L3-L4 IHs between February 2012 and January 2020 were identified. All patients were operated on by the senior surgeons responsible for the complex abdominal wall units of each participating center. Prior to conducting the study, the approval of the local ethics committee was obtained (ID:39/2019). Written informed consent was also obtained.

The diagnosis of IH was based on clinical examination and imaging from a computed tomography (CT). The investigator only included patients with L3-L4 IHs. Patients with primary lateral hernias, such as Spiegel, Grynfelt and Petit hernias were excluded. We also excluded all patients in which the lateral IH was a parastomal hernia.

Demographic data, patient comorbidities, different classifications of hernia complexity, Carolinas Equation for Determining Associated Risks (CeDAR) and intraoperative and postoperative data were collected All patients followed a similar preoperative optimization program, which included endocrinologic and nutritional evaluations, respiratory physiotherapy, and abstinence from smoking at least 1 month before surgery. Weight loss was extremely recommended but without any mandatory prerequisite.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

61

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

  • Spain
      • Madrid, Spain, 28822
        • Miguel Ángel García Ureña

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

All patients undergoing open abdominal wall repair through the previous lateral incision for L3-L4 IHs between February 2012 and January 2020 in the three University Hospitals in Spain involving in the multicentric study

Description

Inclusion Criteria:

  • Patients with a lateral incisional hernia L3 European Hernia Society classification
  • Patients with a lateral incisional hernia L4 European Hernia Society classification
  • Patients older than 18 years old

Exclusion Criteria:

  • Midline incisional hernia.
  • Patients with a parastomal hernia
  • Patients with a primary midline ventral hernia
  • Patients with a primary lateral hernia.
  • Age under 18 years old

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
lateral retromuscular preperitoneal group
All patients undergoing open lateral retromuscular preperitoneal repair through the previous lateral incision for L3-L4 IHs between February 2012 and January 2020
Other: Surgical Technique (lateral retromuscular preperitoneal)
Open abdominal wall repair through the previous lateral incision for L3-L4 Incisional hernias
Other Names:
  • Surgical Technique (reverse TAR)
Reverse TAR group
All patients undergoing open reverse TAR repair through the previous lateral incision for L3-L4 IHs between February 2012 and January 2020

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: At least 12 month
Recurrence was defined as a bulge of the contents of the abdominal cavity or preperitoneal fat through an abdominal wall defect at the site of a previous abdominal wall hernia repair.
At least 12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Occurrence
Time Frame: 30 days
Surgical Site Occurrence: the definition standardized by the Ventral Hernia Working Group (VHWG) was used, which includes any SSI, and wound cellulitis, unhealed incisional wound, fascial disruption, skin or soft tissue ischemia, skin or soft tissue necrosis, serous or purulent drainage wound, suture abscess, seroma, hematoma, infected or exposed mesh, or development of an enterocutaneous fistula
30 days
Surgical Site Occurrence Requiring Procedural Intervention (SSOPI)
Time Frame: 30 days
Surgical Site Occurrence Requiring Procedural Intervention (SSOPI): any SSO requiring wound opening, wound debridement, suture removal, percutaneous drainage, or partial or complete removal of the mesh
30 days
Surgical Site Infection (SSI)
Time Frame: 30 days
Surgical Site Infection (SSI) was defined using the standardized CDC definition: "infection that occurs in the part of the body where surgery has been performed and includes superficial, deep, and organ / space types"
30 days
Bulging
Time Frame: At least 12 month
Bulging was defined as an area of weakness or asymmetry on inspection or exploration of the patient's abdominal wall, with no confirmed defects on CT.
At least 12 month
European Registry for Abdominal Wall Hernias Quality of Life scale ("EuraHS-QoL")
Time Frame: 24 months
Quality of life study was developed using the "European Registry for Abdominal Wall Hernias Quality of Life" scale ("EuraHS-QoL"), a specific tool developed by the EHS, which compares the evolution of the patients between the preoperative and postoperative periods regarding pain, restriction and aesthetic appearance domains. The minimum value is 0 and maximum value is 10. Higher scores mean a worse outcome.
24 months

Collaborators and Investigators

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

Sponsor

Henares University 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)

February 6, 2012

Primary Completion (Actual)

January 13, 2020

Study Completion (Actual)

December 29, 2021

Study Registration Dates

First Submitted

January 11, 2022

First Submitted That Met QC Criteria

January 11, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Actual)

February 7, 2022

Last Update Submitted That Met QC Criteria

January 24, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 39/2019.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

We want to protect all the personal data of the patients participating in the study

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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