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

Colon Cancer Clinical Trial

— ACBC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04450758
• Other study ID #: Skane University Hospital
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 31, 2031

Study information

• Verified date: December 2023
• Source: Skane University Hospital
• Contact: Pamela Buchwald, PhD MD
• Phone: 004640331000
• Email: pamela.buchwald[@]med.lu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2031
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Sweden	Göteborg University	Göteborg

Sponsors (2)

Lead Sponsor	Collaborator
Skane University Hospital	Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with 30-day severe morbidity	Clavien-Dindo >3 within 30 days postop	30 days
Primary	Overall survival after 3 years	survival unspecified	3 years
Primary	Number of patients with 30 day mortality	death within 30 days	30 days
Primary	Overall survival after 5 years	survival unspecified	5 years
Primary	Number of patients with 90 day mortality	death within 90 days	90 days
Secondary	Number of patients with locally radical resections	resections regarded as R0	90 days
Secondary	Number of examined mesenteric lymph nodes	lymph nodes examined by pathologist	90 days
Secondary	Proportion of patients receiving neoadjuvant or adjuvant treatment	patients receiveing chemotherapy	1 year
Secondary	Proportion of patients with stomas after 3 years	patients with bowel continuity without stome	3 years
Secondary	Recurrence rate after 3 after years	relapse within 3 years	3 years
Secondary	Disease-free survival after 3 years	survival without disease relapse after 3 years	3 years
Secondary	Proportion of patients not being subjected to resection of initially decompressed	patients not proceeding to resection	90 days
Secondary	bridging interval	interval between stenting or stoma and resection	90 days
Secondary	Number of stent complications (perforations, migration, bleeding, success rate etc)	complications in stent group	90 days
Secondary	Number of stoma complications	complications in stoma group	90 days
Secondary	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
Secondary	Number of laparoscopic resections	numbers of laparoscopic vs open resections	90 days
Secondary	Number of primary anastomosis	number of primary anastomosis in the Bridge to Surgery vs up front resection group	90 days
Secondary	Number of stomas after resection and type of stoma	number of stomas in Bridge to Surgery vs up front resection group	90 days
Secondary	total hospital stay in days	days in hospital in Bridge to Surgery vs up front resection	90 days
Secondary	colorectal surgeon performing resectional surgery	qualified colorectal surgeon, general surgeon or resident performing resectional surgery	90 days