The Impact of Gut Microbiota in Anastomoses Insufficiency... | NCT04252560

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

NCT04252560

Sponsor

Uppsala University Hospital

Status

Completed

Last Update Posted

May 9, 2024Actual

Enrollment

45Actual

Phase

Not provided

Conditions

Colorectal Cancer, Peritoneal Carcinomatosis, Anastomosis Insufficiency

Interventions

Colectomy, CRS+HIPEC

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 31, 2020Actual

Primary Completion Date

Jan 31, 2024Actual

Completion Date

Jan 31, 2024Actual

First Submitted Date

Jan 31, 2020

First Submission Date that Met QC Criteria

Jan 31, 2020

First Posted Date

Feb 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2024

Last Update Posted Date

May 9, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Konstantinos Tsimogiannis, Principal Investigator, Uppsala University HospitalPrincipal Investigator

Lead Sponsor

Uppsala University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Colorectal		30 patients operated for colorectal cancer	Procedure: Colectomy, CRS+HIPEC
HIPEC		15 patients operated with CRS+HIPEC for peritoneal carcinomatosis	Procedure: Colectomy, CRS+HIPEC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Colectomy, CRS+HIPEC	Procedure	No special interventions are going to be performed. Fecal samples are going to be taken and analysed	Colorectal HIPEC

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uppsala University Hospital		Uppsala		75185	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Description

Not allowed by the Ethical Committee

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D010534	Peritoneal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003082	Colectomy

Ancestor Terms

ID	Term
D000099090	Surgical Procedures, Colorectal
D013505	Digestive System Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided