Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma
- Conditions
- Colon Cancer
- Interventions
- Procedure: Bridge to Surgery (stent or stoma)
- Registration Number
- NCT04450758
- Lead Sponsor
- Skane University Hospital
- 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- 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
- Colonic perforation or bleeding
- Colonic obstruction of other origin than colon cancer
- Palliative situation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description bridge to sugery Bridge to Surgery (stent or stoma) 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.
- Primary Outcome Measures
Name Time Method Number of patients with 30-day severe morbidity 30 days Clavien-Dindo \>3 within 30 days postop
Number of patients with 30 day mortality 30 days death within 30 days
Overall survival after 5 years 5 years survival unspecified
Number of patients with 90 day mortality 90 days death within 90 days
Overall survival after 3 years 3 years survival unspecified
- Secondary Outcome Measures
Name Time Method Proportion of patients receiving neoadjuvant or adjuvant treatment 1 year patients receiveing chemotherapy
Proportion of patients not being subjected to resection of initially decompressed 90 days patients not proceeding to resection
Morbidity and survival and impact of tumour location 5 years 30 day morbidity and mortality depending on tumour location i.e. right or left colon
Number of examined mesenteric lymph nodes 90 days lymph nodes examined by pathologist
Number of stoma complications 90 days complications in stoma group
Number of laparoscopic resections 90 days numbers of laparoscopic vs open resections
bridging interval 90 days interval between stenting or stoma and resection
total hospital stay in days 90 days days in hospital in Bridge to Surgery vs up front resection
Number of patients with locally radical resections 90 days resections regarded as R0
Proportion of patients with stomas after 3 years 3 years patients with bowel continuity without stome
Recurrence rate after 3 after years 3 years relapse within 3 years
Disease-free survival after 3 years 3 years survival without disease relapse after 3 years
Number of stent complications (perforations, migration, bleeding, success rate etc) 90 days complications in stent group
Number of primary anastomosis 90 days number of primary anastomosis in the Bridge to Surgery vs up front resection group
colorectal surgeon performing resectional surgery 90 days qualified colorectal surgeon, general surgeon or resident performing resectional surgery
Number of stomas after resection and type of stoma 90 days number of stomas in Bridge to Surgery vs up front resection group
Trial Locations
- Locations (1)
Göteborg University
🇸🇪Göteborg, Sweden