XGBoost for Predict Incisional Hernia

Incisional Hernia Clinical Trial

— XGB&IncHern  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05718999
• Other study ID #: CI/HRAEB/002/2021
• Secondary ID: CEI/HRAEB/002/20
• Status: Recruiting
• Start date: January 30, 2023
• Est. completion date: November 30, 2023

Study information

• Verified date: February 2023
• Source: Hospital Regional de Alta Especialidad del Bajio
• Contact: Edgard Efren Lozada Hernández, Dr
• Phone: +524772745801
• Email: edgardlozada[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 their choice or the degree of contamination of the abdominal cavity.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 30, 2023
• Est. primary completion date: February 22, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

Diagnostic Test:
• Not intervention
Not having intervention is an observational study

Locations

Country	Name	City	State
Mexico	Hospital regional de Alta Especialidad del bajio	Leon	Guanajuato

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Regional de Alta Especialidad del Bajio

Country where clinical trial is conducted

Mexico, 

References & Publications (7)

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. — View Citation

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 ver — View Citation

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, Muy — View Citation

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 — View Citation

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 pr — View Citation

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, Sm — View Citation

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.jamcollsur — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	24 months
Secondary	Facial dehiscence	Incidence of fascial dehiscence (the fascial dehiscence is the presentation of separation of fascie with leakage of contents from the abdominal cavity	30 days