Incisional HerniaNCT05205213
Stepwise for the Treatment of Lateral Incisional Hernias
An observational study of Incisional Hernia and Abdominal Wall Defect, run by Henares University Hospital at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia, Abdominal Wall Defect, Abdominal Wall Hernia
- What is being tested?
- Surgical Technique (lateral retromuscular preperitoneal)
- How many people
- 61 participants
- Where
- 1 siteSpain
- Study dates
- 6 Feb 2012to 29 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
- Being tested
- Surgical Technique (lateral retromuscular preperitoneal)
- Medical subject headings
- Incisional Hernia, Hernia, Abdominal, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Technique (lateral retromuscular preperitoneal)Other
Also called Surgical Technique (reverse TAR)
Open abdominal wall repair through the previous lateral incision for L3-L4 Incisional hernias
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At least 12 month
Secondary outcomes (5)
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
Measured: 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
Measured: 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"
Measured: 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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start6 Feb 2012
- Primary completion13 Jan 2020
- Study completion29 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henares University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel A ngel Garci-a Urena, Henares University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205213
- Sponsor's protocol ID
- 39/2019.
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We want to protect all the personal data of the patients participating in the study
Publications
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.
PubMed 31875954Haskins 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.
PubMed 29429064Garner 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.
PubMed 3633903Muysoms 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.
PubMed 22527930Muysoms 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.
PubMed 19495920Muysoms 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.
PubMed 23673408
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepwise for the Treatment of Lateral Incisional Hernias
- ClinicalTrials.gov ID
- NCT05205213
- Acronym / sponsor ID
- 39/2019.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Henares University HospitalUniversity, hospital or other
- Study start
- 6 Feb 2012 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 29 Dec 2021 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lateral retromuscular preperitoneal group | – | Other: Surgical Technique (lateral retromuscular preperitoneal)All patients undergoing open lateral retromuscular preperitoneal repair through the previous lateral incision for L3-L4 IHs between February 2012 and January 2020 |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Technique (lateral retromuscular preperitoneal)Also: Surgical Technique (reverse TAR)Open abdominal wall repair through the previous lateral incision for L3-L4 Incisional hernias | Other | lateral retromuscular preperitoneal group |
Primary outcome
Recurrence
Time frame: At least 12 month
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.
5 secondary outcomes
Surgical Site Occurrence
Time frame: 30 days
Surgical Site Occurrence Requiring Procedural Intervention (SSOPI)
Time frame: 30 days
Surgical Site Infection (SSI)
Time frame: 30 days
Bulging
Time frame: At least 12 month
European Registry for Abdominal Wall Hernias Quality of Life scale ("EuraHS-QoL")
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Background: PubMed 31875954Parker 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.
- Background: PubMed 29429064Haskins 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.
- Background: PubMed 3633903Garner 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.
- Background: PubMed 22527930Muysoms 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.
- Results publication: PubMed 19495920Muysoms 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.
- Results publication: PubMed 23673408Muysoms 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.
- Individual participant dataSharing planned: Undecided. We want to protect all the personal data of the patients participating in the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia and Abdominal Wall Defect, run by Henares University Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: At least 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05205213, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.