Clinical Trials Directory

Trials / Completed

CompletedNCT05205213

Stepwise for the Treatment of Lateral Incisional Hernias

Status
Completed
Phase
Study type
Observational
Enrollment
61 (actual)
Sponsor
Henares University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

Summary

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.

Conditions

Interventions

TypeNameDescription
OTHERSurgical Technique (lateral retromuscular preperitoneal)Open abdominal wall repair through the previous lateral incision for L3-L4 Incisional hernias

Timeline

Start date
2012-02-06
Primary completion
2020-01-13
Completion
2021-12-29
First posted
2022-01-25
Last updated
2022-02-07

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT05205213. Inclusion in this directory is not an endorsement.