NCT05718999

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

February 27, 2023

Status Verified

February 1, 2023

Enrollment Period

23 days

First QC Date

January 30, 2023

Last Update Submit

February 23, 2023

Conditions

Incisional Hernia

Outcome Measures

Primary Outcomes (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).

    24 months

Secondary Outcomes (1)

  • Facial dehiscence

    30 days

Study Arms (2)

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.

Diagnostic Test: Not intervention

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.

Diagnostic Test: Not intervention

Interventions

Not interventionDIAGNOSTIC_TEST

Not having intervention is an observational study

With Incisional HerniaWithout Incisional Hernia

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital regional de Alta Especialidad del bajio

León, Guanajuato, 37660, Mexico

RECRUITING

Related Publications (7)

  • 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.

    PMID: 26188742RESULT

  • 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.

    PMID: 28641875RESULT

  • 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.

    PMID: 25618025RESULT

  • 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.

    PMID: 36026550RESULT

  • 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.

    PMID: 33398464RESULT

  • 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.

    PMID: 20113942RESULT

  • 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.

    PMID: 7720497RESULT

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Edgard Efren Lozada Hernández

    Hospital Regional Of High Speciality of Bajio

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edgard Efren Lozada Hernández, Dr

CONTACT

+524772745801edgardlozada@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
24 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Research Level D

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 8, 2023

Study Start

January 30, 2023

Primary Completion

February 22, 2023

Study Completion

November 30, 2023

Last Updated

February 27, 2023

Record last verified: 2023-02

Locations

ME(1)