Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma (ACBC)

Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma: a Prospective Cohort Study

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

Study Overview

• Status: Recruiting
• Conditions: Colon Cancer
• Intervention / Treatment: Procedure: Bridge to Surgery (stent or stoma)

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Pamela Buchwald, PhD MD; Phone Number: 004640331000; Email: pamela.buchwald@med.lu.se
• Study Contact Backup: Name: Caroline Nilsson, RN; Phone Number: 0046331000; Email: caroline.n.nilsson@skane.sese

Study Locations

• Sweden
  • Göteborg, Sweden
    • Recruiting
    • Göteborg University
    • Contact: Jennifer Park, PhD MD; Phone Number: 031-3421000
    • Contact: Forskningssk, RN; Phone Number: 031-3421000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Prospective observational cohort study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with locally radical resections	resections regarded as R0	90 days
Number of examined mesenteric lymph nodes	lymph nodes examined by pathologist	90 days
Proportion of patients receiving neoadjuvant or adjuvant treatment	patients receiveing chemotherapy	1 year
Proportion of patients with stomas after 3 years	patients with bowel continuity without stome	3 years
Recurrence rate after 3 after years	relapse within 3 years	3 years
Disease-free survival after 3 years	survival without disease relapse after 3 years	3 years
Proportion of patients not being subjected to resection of initially decompressed	patients not proceeding to resection	90 days
bridging interval	interval between stenting or stoma and resection	90 days
Number of stent complications (perforations, migration, bleeding, success rate etc)	complications in stent group	90 days
Number of stoma complications	complications in stoma group	90 days
Morbidity and survival and impact of tumour location	30 day morbidity and mortality depending on tumour location i.e. right or left colon	5 years
Number of laparoscopic resections	numbers of laparoscopic vs open resections	90 days
Number of primary anastomosis	number of primary anastomosis in the Bridge to Surgery vs up front resection group	90 days
Number of stomas after resection and type of stoma	number of stomas in Bridge to Surgery vs up front resection group	90 days
total hospital stay in days	days in hospital in Bridge to Surgery vs up front resection	90 days
colorectal surgeon performing resectional surgery	qualified colorectal surgeon, general surgeon or resident performing resectional surgery	90 days

Collaborators and Investigators

• Sponsor: Skane University Hospital
• Collaborators: Göteborg University
• Investigators: Principal Investigator: Pamela Buchwald, PhD MD, Skane University Hospital, Lund University; Study Chair: Tobias Axmarker, MD, Skane University Hospital, Lund University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2031

Study Registration Dates

• First Submitted: June 14, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (Actual): June 30, 2020

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: Skane University Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No