Upgrade Program Implementation at Colorrectal Surgery and Complications: Early Diagnosis

NCT04632446 | Unknown

• 1 other identifier: IMIB-2020-UPCS
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The anastomotic leak (AL) is a very serious complication in colorectal surgery not only because of its severity but its frequency. Other facet for study, besides the risk factor and prevention, is the AL early diagnostic, due to minimize the clinical consequences and severity; and avoid the failure-to-recue. Several studies analyze the Creactive protein (CRP) and Procalcitonine (PCT) usefulness in AL predictor before the clinical signs appear. At a prospective observational study carry on our center, it concluded that CRP at 3rd day after surgery over 15mg/dl was a very important AL predictor, even before the clinical changes appear. The aim of this study is minimize the severity complications and the mortality due to AL appears. The aim of this study is minimize the severity complications and the mortality due to AL by means of introduces an upgrade program in which a CT scan will be conduct in all the patients with high CRP levels at 3rd, 4th or 5th postoperative day, with the goal to know the AL early and make all the therapeutic step to minimize the consequences.

Conditions

Surgery

Outcome Measures

Primary Outcomes (2)

• Severity of morbidity

  Number of reoperations, readmissions for infections associated or other medical complications, terminal stomata

  1 year

• Severity of mortality

  Number of related exits

  1 year

Secondary Outcomes (2)

• - Compare hospital stay and ICU stay of patients undergoing elective colorectal surgery before and after the improvement program.

  1 year

• - Evaluate the difference in the incidence of anastomosis leak after the implementation of the improvement program

  1 year

Interventions

Early diagnosis OTHER

Early diagnosis. Upgrade program implementation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients who underwent elective colorectal surgery consecutively will be included, in which an anastomosis have been performed (neoplastic and non-neoplastic pathology

You may qualify if:

• Patients over 18 years of age.
• Patients undergoing elective colorectal surgery due to neoplastic or non-neoplastic etiology.
• Patients with an anastomosis performed in the surgical act.
• Signed informed consent.

You may not qualify if:

• Patients who require transfer to another center.
• Patients with fatal evolution: those who require urgent reoperation for an inarverted perforation, early leakage of anastomosis or death before the third postoperative day.

Sponsors & Collaborators

• Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia: lead

Study Sites (1)

- Hospital Morales Meseguer

Murcia, 30003, Spain

RECRUITING

Related Publications (1)

• Baeza-Murcia M, Valero-Navarro G, Pellicer-Franco E, Soria-Aledo V, Mengual-Ballester M, Garcia-Marin JA, Betoret-Benavente L, Aguayo-Albasini JL. Early diagnosis of anastomotic leakage in colorectal surgery: prospective observational study of the utility of inflammatory markers and determination of pathological levels. Updates Surg. 2021 Dec;73(6):2103-2111. doi: 10.1007/s13304-021-01082-8. Epub 2021 May 20.

  PMID: 34018141 DERIVED

Study Officials

• Graciela Valero-Navarro, MD

  - Hospital Morales Meseguer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Graciela Valero-Navarro, MD

CONTACT

968360900; valerograciela@um.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 17, 2020
• Study Start: January 15, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2022
• Last Updated: November 17, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)