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Incisional HerniaXGB&IncHernNCT05718999

XGBoost for Predict Incisional Hernia

An observational study of Incisional Hernia, run by Hospital Regional de Alta Especialidad del Bajio at 1 site in Mexico.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this study is to develop a predictive model of IH based on machine learning with the use of the XGBoost technique, this will help surgeons in charge of abdominal wall closure to have objective support to determine high-risk patients and in them modify the closure technique or use a mesh according to… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Incisional Hernia
What is being tested?
Not intervention
How many people
1,000 participants
Where
1 siteMexico
Study dates
30 Jan 2023to 30 Nov 2023
How long will I take part?
24 Months
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 to 80 years
  • All sexes
  • Adult, Older adult

Study population: Patients older than 18 years of age, postoperative midline exploratory laparotomy, who underwent urgent or scheduled surgery, regardless of their underlying diagnosis, were included between January 2010 and December 2016 and who completed 24 months of follow-up after surgery initial surgery.

Who may be able to join

  • Patients older than 18 years of age
  • Postoperative midline exploratory laparotomy, who underwent urgent or scheduled surgery, regardless of their underlying diagnosis,
  • included between January 2010 and December 2016 and who completed 24 months of follow-up after surgery initial surgery.

Who cannot join

  • Reoperated for any cuestion diferent to present of hernia
  • Management of open abdomen

Trial locations and contacts

1 site in 1 country.

Edgard Efren Lozada Hernández, Dr contact

+524772745801

edgardlozada@hotmail.com

Mexico1 site, 1 recruiting

  • Hospital regional de Alta Especialidad del bajio

    León, Guanajuato, 37660

    Edgard Efren Lozada Hernandez, Dr, 4772745801 ext. 1854, edgardlozada2@gmail.com

    Recruiting

Other trials in Mexico

About this study

Official title: Development and Internal Validation of a Machine Learning Model to Predict the Occurrence of Incisional Hernia After a Midline Laparotomy

The objective of this study is to develop a predictive model of IH based on machine learning with the use of the XGBoost technique, this will help surgeons in charge of abdominal wall closure to have objective support to determine high-risk patients and in them modify the closure technique or use a mesh according to their choice or the degree of contamination of the abdominal cavity.

Read the detailed description

Retrospective and observational study. The predictions will make using machine learning models. The programs use the scikit-learn, xgboost and catboost Python packages for modeling.

The evaluation of models will be using fourfold cross-validation, the receiver operating characteristic (ROC) curve, the area under the ROC curve (AUC), and accuracy metrics calculated on the union of the test sets of the cross-validation.

The most critical factors and their contribution to the prediction will identify using a modern tool of explainable artificial intelligence called SHapley Additive exPlanations (SHAP).

Being tested
Not intervention
Medical subject headings
Incisional Hernia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Not interventionDiagnostic test

    Not having intervention is an observational study

Study groups in NCT05718999
Study groupRoleWhat they receive
With Incisional HerniaThe incisional hernia was defined according to the EHS guidelines as a mass in the abdominal wall with or without a visceral outlet or palpable in the surgical site determined by clinical examination or tomography, this group will present this complication.
Receives: Diagnostic Test: Not intervention
Without Incisional HerniaThe incisional hernia was defined according to the EHS guidelines as a mass in the abdominal wall with or without a visceral outlet or palpable in the surgical site determined by clinical examination or tomography, this group will not present this complication.
Receives: Diagnostic Test: Not intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incisional Hernia

    incidence of Incisional hernia (the incisional hernia was defined according to the EHS guidelines as: a mass in the abdominal wall with or without visceral outlet or palpable in the surgical site determined by clinical examination or tomography).

    Measured: 24 months

Secondary outcomes (1)

  1. Facial dehiscence

    Incidence of fascial dehiscence (the fascial dehiscence is the presentation of separation of fascie with leakage of contents from the abdominal cavity

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2023
  2. Study start30 Jan 2023
  3. Primary completion22 Feb 2023
  4. Study completion30 Nov 2023 (estimated)

Resources

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
Prospective
Enrolment
1,000 participants (estimated)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT05718999
Sponsor's protocol ID
CI/HRAEB/002/2021
Other IDs
CEI/HRAEB/002/2021
Acronym
XGB&IncHern
Status last verified
Feb 2023
First submitted
30 Jan 2023
Last updated
27 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Once the database to be analyzed is identified, the presence of other researchers will be verified to certify the veracity of the data.

Publications

  • Deerenberg EB, Harlaar JJ, Steyerberg EW, Lont HE, van Doorn HC, Heisterkamp J, Wijnhoven BP, Schouten WR, Cense HA, Stockmann HB, Berends FJ, Dijkhuizen FPH, Dwarkasing RS, Jairam AP, van Ramshorst GH, Kleinrensink GJ, Jeekel J, Lange JF. Small bites versus large bites for closure of abdominal midline incisions (STITCH): a double-blind, multicentre, randomised controlled trial. Lancet. 2015 Sep 26;386(10000):1254-1260. doi: 10.1016/S0140-6736(15)60459-7. Epub 2015 Jul 15.

    PubMed 26188742

  • Jairam AP, Timmermans L, Eker HH, Pierik REGJM, van Klaveren D, Steyerberg EW, Timman R, van der Ham AC, Dawson I, Charbon JA, Schuhmacher C, Mihaljevic A, Izbicki JR, Fikatas P, Knebel P, Fortelny RH, Kleinrensink GJ, Lange JF, Jeekel HJ; PRIMA Trialist Group. Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement versus primary suture only in midline laparotomies (PRIMA): 2-year follow-up of a multicentre, double-blind, randomised controlled trial. Lancet. 2017 Aug 5;390(10094):567-576. doi: 10.1016/S0140-6736(17)31332-6. Epub 2017 Jun 20.

    PubMed 28641875

  • Muysoms FE, Antoniou SA, Bury K, Campanelli G, Conze J, Cuccurullo D, de Beaux AC, Deerenberg EB, East B, Fortelny RH, Gillion JF, Henriksen NA, Israelsson L, Jairam A, Janes A, Jeekel J, Lopez-Cano M, Miserez M, Morales-Conde S, Sanders DL, Simons MP, Smietanski M, Venclauskas L, Berrevoet F; European Hernia Society. European Hernia Society guidelines on the closure of abdominal wall incisions. Hernia. 2015 Feb;19(1):1-24. doi: 10.1007/s10029-014-1342-5. Epub 2015 Jan 25.

    PubMed 25618025

  • Deerenberg EB, Henriksen NA, Antoniou GA, Antoniou SA, Bramer WM, Fischer JP, Fortelny RH, Gok H, Harris HW, Hope W, Horne CM, Jensen TK, Kockerling F, Kretschmer A, Lopez-Cano M, Malcher F, Shao JM, Slieker JC, de Smet GHJ, Stabilini C, Torkington J, Muysoms FE. Updated guideline for closure of abdominal wall incisions from the European and American Hernia Societies. Br J Surg. 2022 Nov 22;109(12):1239-1250. doi: 10.1093/bjs/znac302.

    PubMed 36026550

  • Lozada-Hernandez EE, Mayagoitia-Gonzalez JC, Smolinski-Kurek RL, Montiel-Hinojosa L, Hernandez-Villegas L, Morales-Vargas JM, Perez-Sanchez KD, Orozco-Mosqueda A, Cano-Rosas M. Prevention of incisional hernia with a reinforced tension line (RTL) versus primary suture only in midline laparotomies: 3-year follow-up in a randomized clinical trial. Hernia. 2022 Apr;26(2):447-456. doi: 10.1007/s10029-020-02338-9. Epub 2021 Jan 5.

    PubMed 33398464

  • Veljkovic R, Protic M, Gluhovic A, Potic Z, Milosevic Z, Stojadinovic A. Prospective clinical trial of factors predicting the early development of incisional hernia after midline laparotomy. J Am Coll Surg. 2010 Feb;210(2):210-9. doi: 10.1016/j.jamcollsurg.2009.10.013.

    PubMed 20113942

  • Cao GW, Yang WG, Du P. [Observation of the effects of LAK/IL-2 therapy combining with Lycium barbarum polysaccharides in the treatment of 75 cancer patients]. Zhonghua Zhong Liu Za Zhi. 1994 Nov;16(6):428-31. Chinese.

    PubMed 7720497

  • Lozada-Hernandez EE, Ramirez-DelReal TA, Salazar-Colores S, Armenta-Medina D. Incisional hernia prediction using machine learning models. BMC Med Inform Decis Mak. 2026 Feb 27;26(1):104. doi: 10.1186/s12911-026-03382-8.

    PubMed 41761228

Questions about this trial

What is this clinical trial studying?

An observational study of Incisional Hernia, run by Hospital Regional de Alta Especialidad del Bajio at 1 site in Mexico.

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 2 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: status not confirmed, as of the sponsor's last update on 27 Feb 2023. 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 Mexico. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Edgard Efren Lozada Hernández, Dr (+524772745801, edgardlozada@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incisional Hernia (time frame: 24 months). 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 NCT05718999, which also lists 8 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 27 Feb 2023.

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