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

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

Sponsors

Lead Sponsor: Skane University Hospital

Collaborator: Göteborg University

Source 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.

Overall Status Recruiting
Start Date September 1, 2020
Completion Date December 31, 2031
Primary Completion Date December 31, 2025
Study Type Observational
Primary Outcome
Measure Time Frame
Number of patients with 30-day severe morbidity 30 days
Overall survival after 3 years 3 years
Number of patients with 30 day mortality 30 days
Overall survival after 5 years 5 years
Number of patients with 90 day mortality 90 days
Secondary Outcome
Measure Time Frame
Number of patients with locally radical resections 90 days
Number of examined mesenteric lymph nodes 90 days
Proportion of patients receiving neoadjuvant or adjuvant treatment 1 year
Proportion of patients with stomas after 3 years 3 years
Recurrence rate after 3 after years 3 years
Disease-free survival after 3 years 3 years
Proportion of patients not being subjected to resection of initially decompressed 90 days
bridging interval 90 days
Number of stent complications (perforations, migration, bleeding, success rate etc) 90 days
Number of stoma complications 90 days
Morbidity and survival and impact of tumour location 5 years
Number of laparoscopic resections 90 days
Number of primary anastomosis 90 days
Number of stomas after resection and type of stoma 90 days
total hospital stay in days 90 days
colorectal surgeon performing resectional surgery 90 days
Enrollment 1000
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Bridge to Surgery (stent or stoma)

Description: 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.

Arm Group Label: bridge to sugery

Eligibility

Sampling Method: Non-Probability Sample

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

Exclusion Criteria:

- Colonic perforation or bleeding

- Colonic obstruction of other origin than colon cancer

Gender: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Pamela Buchwald, PhD MD Principal Investigator Skane University Hospital
Overall Contact

Last Name: Pamela Buchwald, PhD MD

Phone: 0046331000

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Göteborg University Jennifer Park, PhD MD 031-3421000
Location Countries

Sweden

Verification Date

July 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Skane University Hospital

Investigator Full Name: Pamela Buchwald

Investigator Title: consultant colorectal surgeon, associate professor

Has Expanded Access No
Condition Browse
Arm Group

Label: resection

Description: Patients who present with obstruction due to colon cancer with a need for urgent intervention who are treated with acute resection.

Label: bridge to sugery

Description: 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.

Acronym ACBC
Patient Data Yes
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov