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Enrolling by invitation NCT07204665

This Study Has Been Designed to Support the Working Hypothesis That Emergency Surgery in a Colon Obstruction Neoplasm is Better Than Stent Bridge Due to Better Oncological Outcomes, Analyzing the Importance of ERAS Programs in Emergency Colon Obstruction Surgery.

— Observational Colon Obstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Colon Obstruction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

European Study in Colon Obstruction

Overview

This study has been designed to support the working hypothesis that emergency surgery in a colon obstruction neoplasm is better than stent bridge due to better oncological outcomes. The primary objective is to analyse the importance of ERAS program implementation in emergency colon obstruction surgery

Primary outcome measures

  • Postoperative complications [Time frame: From enrollment to 90 days]
Secondary outcome measures (5)
  • 1 year survival analysis [Time frame: 360 days after surgery]
  • Overall survival [Time frame: 365 days after surgery]
  • disease-related survival [Time frame: 365 days after surgery]
  • disease-free survival [Time frame: 365 days after surgery]
  • Relationship between stent bridge and colon perforation [Time frame: 60 days after stent placement]

Eligibility criteria

Inclusion criteria

  • All adult patients (aged >18 years) with a diagnosis of Malignant obstruction colorectal cancer. Informed consent will be obtained from all subjects who will participate in the study voluntarily.
  • ASA I, II and III
  • No more than 5 days from symptoms onset.
  • Absence of proximal colon severe dilatation( no more than 8 centimeters), severe malnutrition.
  • No Inmunocompromised patients
  • Patients suffer from segmentary colectomy, with or without anastomosis with o witjhout lateral ileostomy
  • Patients suffer from Hartmann procedure.

Exclusion criteria

  • Patient refusal.
  • Patients under 18 years of age.
  • ASA IV
  • Stent placement
  • ICU stay more than 2 days
  • Peritonitis
  • Out of protocol if patient would need total parenteral nutrition(NPT) during postoperative or Clavien-Dindo more or equal than II.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Spain · 1 center
  • Hospital de Urduliz — Bilbao

Identifiers

NCT: NCT07204665 · EUCOBS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗