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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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

Condition or disease Intervention/treatment
Colon Cancer 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acute Colon Resection Versus Bridge to Colon Surgery With Stent or Stoma: a Prospective Cohort Study
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2031

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.




Primary Outcome Measures :
  1. Number of patients with 30-day severe morbidity [ Time Frame: 30 days ]
    Clavien-Dindo >3 within 30 days postop

  2. Overall survival after 3 years [ Time Frame: 3 years ]
    survival unspecified

  3. Number of patients with 30 day mortality [ Time Frame: 30 days ]
    death within 30 days

  4. Overall survival after 5 years [ Time Frame: 5 years ]
    survival unspecified

  5. Number of patients with 90 day mortality [ Time Frame: 90 days ]
    death within 90 days


Secondary Outcome Measures :
  1. Number of patients with locally radical resections [ Time Frame: 90 days ]
    resections regarded as R0

  2. Number of examined mesenteric lymph nodes [ Time Frame: 90 days ]
    lymph nodes examined by pathologist

  3. Proportion of patients receiving neoadjuvant or adjuvant treatment [ Time Frame: 1 year ]
    patients receiveing chemotherapy

  4. Proportion of patients with stomas after 3 years [ Time Frame: 3 years ]
    patients with bowel continuity without stome

  5. Recurrence rate after 3 after years [ Time Frame: 3 years ]
    relapse within 3 years

  6. Disease-free survival after 3 years [ Time Frame: 3 years ]
    survival without disease relapse after 3 years

  7. Proportion of patients not being subjected to resection of initially decompressed [ Time Frame: 90 days ]
    patients not proceeding to resection

  8. bridging interval [ Time Frame: 90 days ]
    interval between stenting or stoma and resection

  9. Number of stent complications (perforations, migration, bleeding, success rate etc) [ Time Frame: 90 days ]
    complications in stent group

  10. Number of stoma complications [ Time Frame: 90 days ]
    complications in stoma group

  11. 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

  12. Number of laparoscopic resections [ Time Frame: 90 days ]
    numbers of laparoscopic vs open resections

  13. Number of primary anastomosis [ Time Frame: 90 days ]
    number of primary anastomosis in the Bridge to Surgery vs up front resection group

  14. 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

  15. total hospital stay in days [ Time Frame: 90 days ]
    days in hospital in Bridge to Surgery vs up front resection

  16. colorectal surgeon performing resectional surgery [ Time Frame: 90 days ]
    qualified colorectal surgeon, general surgeon or resident performing resectional surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prospective observational cohort study.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450758


Contacts
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Contact: Pamela Buchwald, PhD MD 0046331000 pamela.buchwald@med.lu.se
Contact: Ingrid Palmquist, RN 0046331000 ingrid.palmquist@med.lu.se

Locations
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Sweden
Göteborg University Recruiting
Göteborg, Sweden
Contact: Jennifer Park, PhD MD    031-3421000      
Contact: Forskningssk, RN    031-3421000      
Sponsors and Collaborators
Skane University Hospital
Göteborg University
Investigators
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Principal Investigator: Pamela Buchwald, PhD MD Skane University Hospital
  Study Documents (Full-Text)

Documents provided by Pamela Buchwald, Skane University Hospital:
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Responsible Party: Pamela Buchwald, consultant colorectal surgeon, associate professor, Skane University Hospital
ClinicalTrials.gov Identifier: NCT04450758    
Other Study ID Numbers: Skane University Hospital
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases