Health TrialsbyHealthPanel

Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma

ConditionColon Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorSkane University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Colonic perforation or bleeding

Colonic obstruction of other origin than colon cancer

Palliative situation

Trial population

Prospective observational cohort study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Bridge to Surgery (stent or stoma)

    Procedure/Surgery

    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.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: resection0 interventions
Group B: bridge to sugery1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with 30-day severe morbidity

Clavien-Dindo \>3 within 30 days postop

Time frame
30 days
2

Overall survival after 3 years

survival unspecified

Time frame
3 years
3

Number of patients with 30 day mortality

death within 30 days

Time frame
30 days
4

Overall survival after 5 years

survival unspecified

Time frame
5 years

Secondary outcomes

1

Number of patients with locally radical resections

resections regarded as R0

Time frame
90 days
2

Number of examined mesenteric lymph nodes

lymph nodes examined by pathologist

Time frame
90 days
3

Proportion of patients receiving neoadjuvant or adjuvant treatment

patients receiveing chemotherapy

Time frame
1 year
4

Proportion of patients with stomas after 3 years

patients with bowel continuity without stome

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Skane University Hospital

Lead sponsor

Göteborg University

Collaborator

Source ClinicalTrials.gov
Apply now