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

NCT ID: NCT04450758

Last Updated: 2023-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2031-12-31

Brief Summary

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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

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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.

Conditions

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Colon Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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resection

Patients who present with obstruction due to colon cancer with a need for urgent intervention who are treated with acute resection.

No interventions assigned to this group

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.

Bridge to Surgery (stent or stoma)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role collaborator

Skane University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pamela Buchwald

consultant colorectal surgeon, associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pamela Buchwald, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Skåne University Hospital, Lund University

Tobias Axmarker, MD

Role: STUDY_CHAIR

Skåne University Hospital, Lund University

Locations

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Göteborg University

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Pamela Buchwald, PhD MD

Role: CONTACT

Phone: 004640331000

Email: [email protected]

Caroline Nilsson, RN

Role: CONTACT

Phone: 0046331000

Email: [email protected]

Facility Contacts

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Jennifer Park, PhD MD

Role: primary

Forskningssk, RN

Role: backup

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Skane University Hospital

Identifier Type: -

Identifier Source: org_study_id