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NCT Number: NCT04450758

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

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

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Göteborg University

Gothenburg, Sweden

Location status: Recruiting

Location contact

Forskningssk, RN

CONTACT

031-3421000

Jennifer Park, PhD MD

CONTACT

031-3421000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bridge to Surgery (stent or stoma)

Procedure

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 outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Nilsson, RN

CONTACT

[email protected]

0046331000

Pamela Buchwald, PhD MD

CONTACT

[email protected]

004640331000

Sponsors and collaborators

Lead sponsor

Skane University Hospital

Other

Collaborators

  • Göteborg University

Registry information

Official study title

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

Acronym: ACBC

Important dates

Study start
2020
Primary completion
2029
Study completion
2031
First posted
Jun 30, 2020
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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