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OpenTrials
Completed

NCT Number: NCT04252560

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

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.

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Key information

Conditions

Colorectal Cancer, Peritoneal Carcinomatosis, Anastomosis Insufficiency Abdominal Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Peritoneal Diseases Peritoneal Neoplasms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University Hospital

Uppsala, 75185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colectomy, CRS+HIPEC

Procedure

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

Primary outcomes

  1. Microbiome

    Time frame: 30 days

    Change in microbiome in case of insufficiency of the anastomosis

Sponsors and collaborators

Lead sponsor

Uppsala University Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2020
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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