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

• Sponsor: Uppsala University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04252560
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer, Peritoneal Carcinomatosis, Anastomosis Insufficiency	Procedure: Colectomy, CRS+HIPEC

Study Design

• Study Type: Observational
• Anticipated Enrollment: 45 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Impact of Gut Microbiota in Anastomoses Insufficiency After Resection and Direct Anastomosis for Colorectal Cancer.
• Actual Study Start Date: Jan 31, 2020
• Anticipated Primary Completion Date: Jan 31, 2024
• Anticipated Study Completion Date: Jan 31, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Microbiome [30 days]

   Change in microbiome in case of insufficiency of the anastomosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uppsala University Hospital	Uppsala		Sweden	75185

Sponsors and Collaborators

• Uppsala University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Konstantinos Tsimogiannis, Principal Investigator, Uppsala University Hospital
• ClinicalTrials.gov Identifier: NCT04252560
• Other Study ID Numbers: 2019-04562
• First Posted: Feb 5, 2020
• Last Update Posted: Jun 9, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Colorectal Neoplasms; Carcinoma; Peritoneal Neoplasms

Study Results

No Results Posted as of Jun 9, 2022