Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma
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
- The protocol lists: Bridge to Surgery (stent or stoma).
- Who it may be relevant to
- Registry conditions: Colon Cancer. Basic parameters: 18 years — 100 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
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma: a Prospective Cohort Study
Overview
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
Detailed description
The aim of this prospective observational study is to evaluate primary resection for malignant obstruction of the colon compared to only decompression as first intervention regarding postoperative outcomes. We hypothesize that patients with malignant obstruction benefit from avoidance of emergency cancer resection, by a two-stage procedure, with decompression by a stoma or stent as first intervention, leading to decreased short-term morbidity and mortality and improved long-term oncological outcome.
Interventions
- Procedure Bridge to Surgery (stent or stoma)
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.
Primary outcome measures
- Number of patients with 30-day severe morbidity [Time frame: 30 days]
- Overall survival after 3 years [Time frame: 3 years]
- Number of patients with 30 day mortality [Time frame: 30 days]
- Overall survival after 5 years [Time frame: 5 years]
- Number of patients with 90 day mortality [Time frame: 90 days]
Secondary outcome measures (12)
- Number of patients with locally radical resections [Time frame: 90 days]
- Number of examined mesenteric lymph nodes [Time frame: 90 days]
- Proportion of patients receiving neoadjuvant or adjuvant treatment [Time frame: 1 year]
- Proportion of patients with stomas after 3 years [Time frame: 3 years]
- Recurrence rate after 3 after years [Time frame: 3 years]
- Disease-free survival after 3 years [Time frame: 3 years]
- Proportion of patients not being subjected to resection of initially decompressed [Time frame: 90 days]
- bridging interval [Time frame: 90 days]
- Number of stent complications (perforations, migration, bleeding, success rate etc) [Time frame: 90 days]
- Number of stoma complications [Time frame: 90 days]
- Morbidity and survival and impact of tumour location [Time frame: 5 years]
- Number of laparoscopic resections [Time frame: 90 days]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Colonic perforation or bleeding
- Colonic obstruction of other origin than colon cancer
- Palliative situation
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
Sweden · 1 center
- Göteborg University — Gothenburg
Identifiers
NCT: NCT04450758 · Skane University Hospital