An observational study in Incisional Hernia, Abdominal Wall Defect and Abdominal Wall Hernia, sponsored by Henares University Hospital. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-07.
Sponsored by Henares University Hospital · Observational
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.
212 studies on the registry are indexed under Incisional Hernia; 58 are open to participants now.
This study's enrollment of 61 is below the median of 150 across 75 observational studies indexed under Incisional Hernia.
Browse Incisional Hernia studies →Henares University Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.
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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
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Exclusion Criteria:
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)
All patients undergoing open reverse TAR repair through the previous lateral incision for L3-L4 IHs between February 2012 and January 2020
Open abdominal wall repair through the previous lateral incision for L3-L4 Incisional hernias
Also known as: Surgical Technique (reverse TAR)
Recurrence
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.
Time frame: At least 12 month
Surgical Site Occurrence
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
Time frame: 30 days
Surgical Site Occurrence Requiring Procedural Intervention (SSOPI)
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
Time frame: 30 days
Surgical Site Infection (SSI)
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"
Time frame: 30 days
Bulging
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.
Time frame: At least 12 month
European Registry for Abdominal Wall Hernias Quality of Life scale ("EuraHS-QoL")
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.
Time frame: 24 months
Plan to share: Undecided — We want to protect all the personal data of the patients participating in the study
Ran from Feb 2012 to primary completion in Jan 2020, 95 months.
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This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Henares University Hospital