Study Results
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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UNKNOWN
1000 participants
OBSERVATIONAL
2023-01-30
2023-11-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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With Incisional Hernia
The 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.
Not intervention
Not having intervention is an observational study
Without Incisional Hernia
The 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.
Not intervention
Not having intervention is an observational study
Interventions
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Not intervention
Not having intervention is an observational study
Eligibility Criteria
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Inclusion Criteria
* 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
* Management of open abdomen
18 Years
80 Years
ALL
No
Sponsors
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Hospital Regional de Alta Especialidad del Bajio
OTHER
Responsible Party
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Edgard Lozada
Clinical Research Level D
Principal Investigators
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Edgard Efren Lozada Hernández
Role: PRINCIPAL_INVESTIGATOR
Hospital Regional Of High Speciality of Bajio
Locations
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Hospital regional de Alta Especialidad del bajio
León, Guanajuato, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CEI/HRAEB/002/2021
Identifier Type: OTHER
Identifier Source: secondary_id
CI/HRAEB/002/2021
Identifier Type: -
Identifier Source: org_study_id
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