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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04252560
Other study ID # 2019-04562
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 31, 2020
Est. completion date January 31, 2024

Study information

Verified date May 2024
Source Uppsala University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date January 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Colectomy, CRS+HIPEC
No special interventions are going to be performed. Fecal samples are going to be taken and analysed

Locations

Country Name City State
Sweden Uppsala University Hospital Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Microbiome Change in microbiome in case of insufficiency of the anastomosis 30 days