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RecruitingNCT04450758ACBCUpdated Apr 23, 2026

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

An observational study in Colon Cancer, sponsored by Skane University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Skane University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 100 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Colon Cancer

Browse trials for

03

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Prospective observational cohort study.

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

Exclusion Criteria:

  • Colonic perforation or bleeding
  • Colonic obstruction of other origin than colon cancer
  • Palliative situation
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and 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.

    Procedure: Bridge to Surgery (stent or stoma)

Interventions

  • ProcedureBridge 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.

05

What researchers measure

Primary outcomes

  1. Number of patients with 30-day severe morbidity

    Clavien-Dindo \>3 within 30 days postop

    Time frame: 30 days

  2. Overall survival after 3 years

    survival unspecified

    Time frame: 3 years

  3. Number of patients with 30 day mortality

    death within 30 days

    Time frame: 30 days

  4. Overall survival after 5 years

    survival unspecified

    Time frame: 5 years

  5. Number of patients with 90 day mortality

    death within 90 days

    Time frame: 90 days

Secondary outcomes

  1. Number of patients with locally radical resections

    resections regarded as R0

    Time frame: 90 days

  2. Number of examined mesenteric lymph nodes

    lymph nodes examined by pathologist

    Time frame: 90 days

  3. Proportion of patients receiving neoadjuvant or adjuvant treatment

    patients receiveing chemotherapy

    Time frame: 1 year

  4. Proportion of patients with stomas after 3 years

    patients with bowel continuity without stome

    Time frame: 3 years

  5. Recurrence rate after 3 after years

    relapse within 3 years

    Time frame: 3 years

  6. Disease-free survival after 3 years

    survival without disease relapse after 3 years

    Time frame: 3 years

  7. Proportion of patients not being subjected to resection of initially decompressed

    patients not proceeding to resection

    Time frame: 90 days

  8. bridging interval

    interval between stenting or stoma and resection

    Time frame: 90 days

  9. Number of stent complications (perforations, migration, bleeding, success rate etc)

    complications in stent group

    Time frame: 90 days

  10. Number of stoma complications

    complications in stoma group

    Time frame: 90 days

  11. Morbidity and survival and impact of tumour location

    30 day morbidity and mortality depending on tumour location i.e. right or left colon

    Time frame: 5 years

  12. Number of laparoscopic resections

    numbers of laparoscopic vs open resections

    Time frame: 90 days

  13. Number of primary anastomosis

    number of primary anastomosis in the Bridge to Surgery vs up front resection group

    Time frame: 90 days

  14. Number of stomas after resection and type of stoma

    number of stomas in Bridge to Surgery vs up front resection group

    Time frame: 90 days

  15. total hospital stay in days

    days in hospital in Bridge to Surgery vs up front resection

    Time frame: 90 days

  16. colorectal surgeon performing resectional surgery

    qualified colorectal surgeon, general surgeon or resident performing resectional surgery

    Time frame: 90 days

06

Study locations

1 of 1 sites recruiting
  • Göteborg University
    Gothenburg, Sweden
    • Jennifer Park, PhD MD · Contact · 031-3421000
    • Forskningssk, RN · Contact · 031-3421000
    Recruiting
07

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 17, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

08

Registry details

Key details

Study ID
NCT04450758
Lead sponsor
Skane University Hospital
Collaborators
Göteborg University
Responsible party
Pamela Buchwald (consultant colorectal surgeon, associate professor, Skane University Hospital) — Principal investigator
First posted
Jun 30, 2020
Start date
Sep 1, 2020
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Apr 23, 2026

Study contacts

Pamela Buchwald, PhD MD
Contact
pamela.buchwald@med.lu.se
004640331000
Caroline Nilsson, RN
Contact
caroline.n.nilsson@skane.sese
0046331000
Pamela Buchwald, PhD MD
principal investigator · Skåne University Hospital, Lund University
Tobias Axmarker, MD
study chair · Skåne University Hospital, Lund University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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