NCT04450758

Brief Summary

P) patients with acute obstructive colon cancer I) resection or bridge to surgery with stent or stoma C) emergency procedure O ) morbidity and mortality within 30 days, 90 day mortality and 3 \& 5 years overall survival

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
68mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress51%
Sep 2020Dec 2031

First Submitted

Initial submission to the registry

June 14, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

9.3 years

First QC Date

June 14, 2020

Last Update Submit

April 22, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Number of patients with 30-day severe morbidity

    Clavien-Dindo \>3 within 30 days postop

    30 days

  • Overall survival after 3 years

    survival unspecified

    3 years

  • Number of patients with 30 day mortality

    death within 30 days

    30 days

  • Overall survival after 5 years

    survival unspecified

    5 years

  • Number of patients with 90 day mortality

    death within 90 days

    90 days

Secondary Outcomes (16)

  • Number of patients with locally radical resections

    90 days

  • Number of examined mesenteric lymph nodes

    90 days

  • Proportion of patients receiving neoadjuvant or adjuvant treatment

    1 year

  • Proportion of patients with stomas after 3 years

    3 years

  • Recurrence rate after 3 after years

    3 years

  • +11 more secondary outcomes

Study Arms (2)

resection

Patients who present with obstruction due to colon cancer with a need for urgent intervention who are treated with acute resection.

bridge to sugery

Patients who present with obstruction due to colon cancer with a need for urgent intervention who are treated with bridge to surgery i.e. either stent or stoma and resection later on.

Procedure: Bridge to Surgery (stent or stoma)

Interventions

The study is an observational study and patients will not be randomized. Resection is defined as upfront surgical resection, Bridge to Surgery as a two stage procedure.

bridge to sugery

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Prospective observational cohort study.

You may qualify if:

  • Age \>18 years
  • Symptomatic large bowel obstruction requiring acute intervention
  • CT-verified colon obstruction due to colon cancer independent of presence of metastases
  • Informed consent

You may not qualify if:

  • Colonic perforation or bleeding
  • Colonic obstruction of other origin than colon cancer
  • Palliative situation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Göteborg University

Gothenburg, Sweden

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Stents

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Pamela Buchwald, PhD MD

    Skåne University Hospital, Lund University

    PRINCIPAL INVESTIGATOR
  • Tobias Axmarker, MD

    Skåne University Hospital, Lund University

    STUDY CHAIR

Central Study Contacts

Pamela Buchwald, PhD MD

CONTACT

Caroline Nilsson, RN

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
consultant colorectal surgeon, associate professor

Study Record Dates

First Submitted

June 14, 2020

First Posted

June 30, 2020

Study Start

September 1, 2020

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2031

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations