NCT05205213

Stepwise for the Treatment of Lateral Incisional Hernias

Completed Last updated 7 February 2022

What this trial tests

trial testing Surgical Technique (lateral retromuscular preperitoneal) in Incisional Hernia in 61 participants. Completed in 29 December 2021.

Timeline

6 February 2012

Primary endpoint
13 January 2020

29 December 2021

Quick facts

Lead sponsor	Henares University Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	61
Start date	6 February 2012
Primary completion	13 January 2020
Estimated completion	29 December 2021
Sites	1 location across Spain

Drugs / interventions tested

• Surgical Technique (lateral retromuscular preperitoneal)

Conditions studied

• Incisional Hernia — all drugs for Incisional Hernia →
• Abdominal Wall Defect — all drugs for Abdominal Wall Defect →
• Abdominal Wall Hernia — all drugs for Abdominal Wall Hernia →
• Hernia — all drugs for Hernia →

Sponsor

Henares University Hospital

Who can join

18 and older, any sex, with Incisional Hernia or Abdominal Wall Defect. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.