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

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ClinicalTrials.gov Identifier: NCT04450758
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Pamela Buchwald, Skane University Hospital

Tracking Information
First Submitted Date June 14, 2020
First Posted Date June 30, 2020
Last Update Posted Date July 7, 2020
Estimated Study Start Date September 1, 2020
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2020)
  • Number of patients with 30-day severe morbidity [ Time Frame: 30 days ]
    Clavien-Dindo >3 within 30 days postop
  • Overall survival after 3 years [ Time Frame: 3 years ]
    survival unspecified
  • Number of patients with 30 day mortality [ Time Frame: 30 days ]
    death within 30 days
  • Overall survival after 5 years [ Time Frame: 5 years ]
    survival unspecified
  • Number of patients with 90 day mortality [ Time Frame: 90 days ]
    death within 90 days
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 1, 2020)
  • Number of patients with locally radical resections [ Time Frame: 90 days ]
    resections regarded as R0
  • Number of examined mesenteric lymph nodes [ Time Frame: 90 days ]
    lymph nodes examined by pathologist
  • Proportion of patients receiving neoadjuvant or adjuvant treatment [ Time Frame: 1 year ]
    patients receiveing chemotherapy
  • Proportion of patients with stomas after 3 years [ Time Frame: 3 years ]
    patients with bowel continuity without stome
  • Recurrence rate after 3 after years [ Time Frame: 3 years ]
    relapse within 3 years
  • Disease-free survival after 3 years [ Time Frame: 3 years ]
    survival without disease relapse after 3 years
  • Proportion of patients not being subjected to resection of initially decompressed [ Time Frame: 90 days ]
    patients not proceeding to resection
  • bridging interval [ Time Frame: 90 days ]
    interval between stenting or stoma and resection
  • Number of stent complications (perforations, migration, bleeding, success rate etc) [ Time Frame: 90 days ]
    complications in stent group
  • Number of stoma complications [ Time Frame: 90 days ]
    complications in stoma group
  • Morbidity and survival and impact of tumour location [ Time Frame: 5 years ]
    30 day morbidity and mortality depending on tumour location i.e. right or left colon
  • Number of laparoscopic resections [ Time Frame: 90 days ]
    numbers of laparoscopic vs open resections
  • Number of primary anastomosis [ Time Frame: 90 days ]
    number of primary anastomosis in the Bridge to Surgery vs up front resection group
  • Number of stomas after resection and type of stoma [ Time Frame: 90 days ]
    number of stomas in Bridge to Surgery vs up front resection group
  • total hospital stay in days [ Time Frame: 90 days ]
    days in hospital in Bridge to Surgery vs up front resection
  • colorectal surgeon performing resectional surgery [ Time Frame: 90 days ]
    qualified colorectal surgeon, general surgeon or resident performing resectional surgery
Original Secondary Outcome Measures
 (submitted: June 24, 2020)
  • Number of patients with locally radical resections [ Time Frame: 90 days ]
    resections regarded as R0
  • Number of examined mesenteric lymph nodes [ Time Frame: 90 days ]
    lymph nodes examined by pathologist
  • Proportion of patients receiving neoadjuvant or adjuvant treatment [ Time Frame: 1 year ]
    patients receiveing chemotherapy
  • Proportion of patients with stomas after 3 years [ Time Frame: 3 years ]
    patients with bowel continuity without stome
  • Recurrence rate after 3 after years [ Time Frame: 3 years ]
    relapse within 3 years
  • Disease-free survival after 3 years [ Time Frame: 3 years ]
    survival without disease relapse after 3 years
  • Proportion of patients not being subjected to resection of initially decompressed [ Time Frame: 90 days ]
    patients not proceeding to resection
  • bridging interval [ Time Frame: 90 days ]
    interval between stenting or stoma and resection
  • Number of stent complications (perforations, migration, bleeding, success rate etc) [ Time Frame: 90 days ]
    complications in stent group
  • Number of stoma complications [ Time Frame: 90 days ]
    complications in stoma group
  • Morbidity and survival and impact of tumour location [ Time Frame: 5 years ]
    30 day morbidity and mortality depending on tumour location i.e. right or left colon
  • Number of laparoscopic resections [ Time Frame: 90 days ]
    numbers of laparoscopic vs open resections
  • Number of primary anastomosis [ Time Frame: 90 days ]
    number of primary anastomosis in the Bridge to Surgery vs up front resection group
  • Number of stomas after resection and type of stoma [ Time Frame: 90 days ]
    number of stomas in Bridge to Surgery vs up front resection group
  • total hospital stay in days [ Time Frame: 90 days ]
    days in hospital in Bridge to Surgery vs up front resection
  • qualification of operating surgeon [ Time Frame: 90 days ]
    general or colorectal surgeon performing resection
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Prospective observational cohort study.
Condition Colon Cancer
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.
Study Groups/Cohorts
  • 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.
    Intervention: Procedure: Bridge to Surgery (stent or stoma)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 24, 2020)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2031
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
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

Exclusion Criteria:

  • Colonic perforation or bleeding
  • Colonic obstruction of other origin than colon cancer
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pamela Buchwald, PhD MD 0046331000 pamela.buchwald@med.lu.se
Contact: Ingrid Palmquist, RN 0046331000 ingrid.palmquist@med.lu.se
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT04450758
Other Study ID Numbers Skane University Hospital
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Responsible Party Pamela Buchwald, Skane University Hospital
Study Sponsor Skane University Hospital
Collaborators Göteborg University
Investigators
Principal Investigator: Pamela Buchwald, PhD MD Skane University Hospital
PRS Account Skane University Hospital
Verification Date July 2020