Clinical trial NCT04450758: Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma
Official title: Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colon Cancer
Lead sponsor: Skane University Hospital
Sponsor class: OTHER
Collaborators: name: Göteborg University
First posted: 2020-06-30
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective observational cohort study.

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.

Eligibility 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
* Informed consent

Exclusion Criteria:

* Colonic perforation or bleeding
* Colonic obstruction of other origin than colon cancer
* Palliative situation

Primary outcomes:
measure: Number of patients with 30-day severe morbidity
timeFrame: 30 days
measure: Overall survival after 3 years
timeFrame: 3 years
measure: Number of patients with 30 day mortality
timeFrame: 30 days
measure: Overall survival after 5 years
timeFrame: 5 years
measure: Number of patients with 90 day mortality
timeFrame: 90 days
Secondary outcomes:
measure: Number of patients with locally radical resections
timeFrame: 90 days
measure: Number of examined mesenteric lymph nodes
timeFrame: 90 days
measure: Proportion of patients receiving neoadjuvant or adjuvant treatment
timeFrame: 1 year
measure: Proportion of patients with stomas after 3 years
timeFrame: 3 years
measure: Recurrence rate after 3 after years
timeFrame: 3 years
measure: Disease-free survival after 3 years
timeFrame: 3 years
measure: Proportion of patients not being subjected to resection of initially decompressed
timeFrame: 90 days
measure: bridging interval
timeFrame: 90 days
measure: Number of stent complications (perforations, migration, bleeding, success rate etc)
timeFrame: 90 days
measure: Number of stoma complications
timeFrame: 90 days
measure: Morbidity and survival and impact of tumour location
timeFrame: 5 years
measure: Number of laparoscopic resections
timeFrame: 90 days
measure: Number of primary anastomosis
timeFrame: 90 days
measure: Number of stomas after resection and type of stoma
timeFrame: 90 days
measure: total hospital stay in days
timeFrame: 90 days
measure: colorectal surgeon performing resectional surgery
timeFrame: 90 days
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Göteborg University
Study officials:
affiliation: Skåne University Hospital, Lund University
name: Pamela Buchwald, PhD MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skåne University Hospital, Lund University
name: Tobias Axmarker, MD
role: STUDY_CHAIR
References: