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

NCT ID: NCT04252560

Last Updated: 2024-05-09

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-31

Study Completion Date

2024-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer, Peritoneal Carcinomatosis, Anastomosis Insufficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Colorectal

30 patients operated for colorectal cancer

Colectomy, CRS+HIPEC

Intervention Type PROCEDURE

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

Colectomy, CRS+HIPEC

Intervention Type PROCEDURE

No special interventions are going to be performed. Fecal samples are going to be taken and analysed

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colectomy, CRS+HIPEC

No special interventions are going to be performed. Fecal samples are going to be taken and analysed

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Uppsala University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Konstantinos Tsimogiannis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uppsala University Hospital

Uppsala, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-04562

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.