NCT07204665

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Progress47%
Jul 2025Apr 2027

Study Start

First participant enrolled

July 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 2, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Expected
Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

September 24, 2025

Last Update Submit

September 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative complications

    The primary objective is to analyse the importance of ERAS program implementation in emergency colon obstruction surgery

    From enrollment to 90 days

Secondary Outcomes (5)

  • 1 year survival analysis

    360 days after surgery

  • Overall survival

    365 days after surgery

  • disease-related survival

    365 days after surgery

  • disease-free survival

    365 days after surgery

  • Relationship between stent bridge and colon perforation

    60 days after stent placement

Study Arms (2)

Urgent

Patients with urgent surgery

Elective

Patients with elective surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (aged \>18 years) with a diagnosis of Malignant obstruction colorectal cancer.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Urduliz

Bilbao, Vizcaya, 49600, Spain

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

September 24, 2025

First Posted

October 2, 2025

Study Start

July 1, 2025

Primary Completion

April 30, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

October 2, 2025

Record last verified: 2025-09

Locations