Stepwise for the Treatment of Lateral Incisional Hernias

NCT05205213 | Completed

• 1 other identifier: 39/2019.
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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

Incisional Hernia; Abdominal Wall Defect; Abdominal Wall Hernia; Hernia

Outcome Measures

Primary Outcomes (1)

• 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.

  At least 12 month

Secondary Outcomes (5)

• Surgical Site Occurrence

  30 days

• Surgical Site Occurrence Requiring Procedural Intervention (SSOPI)

  30 days

• Surgical Site Infection (SSI)

  30 days

• Bulging

  At least 12 month

• European Registry for Abdominal Wall Hernias Quality of Life scale ("EuraHS-QoL")

  24 months

Study Arms (2)

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)

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

Interventions

Surgical Technique (lateral retromuscular preperitoneal) OTHER

Open abdominal wall repair through the previous lateral incision for L3-L4 Incisional hernias

Also known as: Surgical Technique (reverse TAR)

lateral retromuscular preperitoneal group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henares University Hospital: lead

Study Sites (1)

Miguel Angel Garcia Ureña

Madrid, 28822, Spain

Location

Related Publications (6)

• Parker SG, Halligan S, Liang MK, Muysoms FE, Adrales GL, Boutall A, de Beaux AC, Dietz UA, Divino CM, Hawn MT, Heniford TB, Hong JP, Ibrahim N, Itani KMF, Jorgensen LN, Montgomery A, Morales-Conde S, Renard Y, Sanders DL, Smart NJ, Torkington JJ, Windsor ACJ. International classification of abdominal wall planes (ICAP) to describe mesh insertion for ventral hernia repair. Br J Surg. 2020 Feb;107(3):209-217. doi: 10.1002/bjs.11400. Epub 2019 Dec 25.

  PMID: 31875954 BACKGROUND

• Haskins IN, Horne CM, Krpata DM, Prabhu AS, Tastaldi L, Perez AJ, Rosenblatt S, Poulose BK, Rosen MJ. A call for standardization of wound events reporting following ventral hernia repair. Hernia. 2018 Oct;22(5):729-736. doi: 10.1007/s10029-018-1748-6. Epub 2018 Feb 10.

  PMID: 29429064 BACKGROUND

• Garner JS. CDC guideline for prevention of surgical wound infections, 1985. Supersedes guideline for prevention of surgical wound infections published in 1982. (Originally published in November 1985). Revised. Infect Control. 1986 Mar;7(3):193-200. doi: 10.1017/s0195941700064080. No abstract available.

  PMID: 3633903 BACKGROUND

• Muysoms F, Campanelli G, Champault GG, DeBeaux AC, Dietz UA, Jeekel J, Klinge U, Kockerling F, Mandala V, Montgomery A, Morales Conde S, Puppe F, Simmermacher RK, Smietanski M, Miserez M. EuraHS: the development of an international online platform for registration and outcome measurement of ventral abdominal wall hernia repair. Hernia. 2012 Jun;16(3):239-50. doi: 10.1007/s10029-012-0912-7. Epub 2012 Apr 18.

  PMID: 22527930 BACKGROUND

• Muysoms FE, Miserez M, Berrevoet F, Campanelli G, Champault GG, Chelala E, Dietz UA, Eker HH, El Nakadi I, Hauters P, Hidalgo Pascual M, Hoeferlin A, Klinge U, Montgomery A, Simmermacher RK, Simons MP, Smietanski M, Sommeling C, Tollens T, Vierendeels T, Kingsnorth A. Classification of primary and incisional abdominal wall hernias. Hernia. 2009 Aug;13(4):407-14. doi: 10.1007/s10029-009-0518-x. Epub 2009 Jun 3.

  PMID: 19495920 RESULT

• Muysoms FE, Deerenberg EB, Peeters E, Agresta F, Berrevoet F, Campanelli G, Ceelen W, Champault GG, Corcione F, Cuccurullo D, DeBeaux AC, Dietz UA, Fitzgibbons RJ Jr, Gillion JF, Hilgers RD, Jeekel J, Kyle-Leinhase I, Kockerling F, Mandala V, Montgomery A, Morales-Conde S, Simmermacher RK, Schumpelick V, Smietanski M, Walgenbach M, Miserez M. Recommendations for reporting outcome results in abdominal wall repair: results of a Consensus meeting in Palermo, Italy, 28-30 June 2012. Hernia. 2013 Aug;17(4):423-33. doi: 10.1007/s10029-013-1108-5. Epub 2013 May 15.

  PMID: 23673408 RESULT

MeSH Terms

Conditions

Incisional Hernia; Hernia, Abdominal; Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of General Surgery Service

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 25, 2022
• Study Start: February 6, 2012
• Primary Completion: January 13, 2020
• Study Completion: December 29, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-01

Locations

ES (1)