Stepwise for the Treatment of Lateral Incisional Hernias

NCT ID: NCT05205213

Last Updated: 2022-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-06

Study Completion Date

2021-12-29

Brief Summary

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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.

Detailed Description

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Conditions

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Incisional Hernia Abdominal Wall Defect Abdominal Wall Hernia Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Surgical Technique (lateral retromuscular preperitoneal)

Intervention Type OTHER

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

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

No interventions assigned to this group

Interventions

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Surgical Technique (lateral retromuscular preperitoneal)

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

Intervention Type OTHER

Other Intervention Names

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Surgical Technique (reverse TAR)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henares University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Miguel A ngel Garci-a Urena

Head of General Surgery Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Miguel Angel Garcia Ureña

Madrid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 29429064 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3633903 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22527930 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31875954 (View on PubMed)

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.

Reference Type RESULT
PMID: 19495920 (View on PubMed)

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.

Reference Type RESULT
PMID: 23673408 (View on PubMed)

Other Identifiers

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39/2019.

Identifier Type: -

Identifier Source: org_study_id

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