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

Recruiting

• Conditions: Colon Cancer

• 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.

Study Timeline

• Study First Submitted: 2020-06-14
• Study First Submitted QC: 2020-06-24
• Study First Posted: 2020-06-30
• Study Start: 2020-09-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-17
• Last Update Posted: 2023-12-19
• Primary Completion: 2025-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival after 5 years	5 years	survival unspecified
Number of patients with 30 day mortality	30 days	death within 30 days
Number of patients with 90 day mortality	90 days	death within 90 days
Number of patients with 30-day severe morbidity	30 days	Clavien-Dindo \>3 within 30 days postop
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
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
Proportion of patients not being subjected to resection of initially decompressed	90 days	patients not proceeding to resection
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