The Impact of Gut Microbiota in Anastomoses Insufficiency After Resection and Direct Anastomosis for Colorectal Cancer.

May 8, 2024 updated by: Konstantinos Tsimogiannis, Uppsala University Hospital
The role of gut microbiota in anastomosis insufficiency in patients operated for colorectal cancer and for peritoneal carcinomatosis is going to be investigated. This is a pilot study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 75185
        • Uppsala University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All patients who meet the inclusion criteria and have none of the exclusion criteria are going to be asked to participate in the study

Description

Inclusion Criteria Colorectal group

  • adenocarcinom in colon or rektum
  • curative operation planed
  • direct anastomose plan
  • elective surgery

Inclusion Criteria HIPEC group :

  • All patients with appendix, colon or rectal cancer accepted for CRS+HIPEC

Exclusion Criteria:

  • Ongoing antibiotics treatment
  • antibiotics treatment in the last 6 months
  • acute surgery
  • palliative surgery
  • Ulcerös colitis or Crohns disease
  • Prior colectomy
  • Small intestine stoma before the operation
  • neoadjuvant treatment
  • Colon preparation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Colorectal
30 patients operated for colorectal cancer
Procedure: Colectomy, CRS+HIPEC
No special interventions are going to be performed. Fecal samples are going to be taken and analysed
HIPEC
15 patients operated with CRS+HIPEC for peritoneal carcinomatosis
Procedure: Colectomy, CRS+HIPEC
No special interventions are going to be performed. Fecal samples are going to be taken and analysed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiome
Time Frame: 30 days
Change in microbiome in case of insufficiency of the anastomosis
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2020

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

January 31, 2020

First Submitted That Met QC Criteria

January 31, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-04562

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Not allowed by the Ethical Committee

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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