Colorectal Cancer, Peritoneal Carcinomatosis, Anastomosis InsufficiencyNCT04252560
The Impact of Gut Microbiota in Anastomoses Insufficiency After Resection and Direct Anastomosis for Colorectal Cancer.
An observational study of Colorectal Cancer, Peritoneal Carcinomatosis, Anastomosis Insufficiency, run by Uppsala University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Peritoneal Carcinomatosis, Anastomosis Insufficiency
- What is being tested?
- Colectomy, CRS+HIPEC
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteSweden
- Study dates
- 31 Jan 2020to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- 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
Who cannot join
- Ongoing antibiotics treatment
- antibiotics treatment in the last 6 months
- acute surgery
- palliative surgery
- Ulcerös colitis or Crohns disease
- Prior colectomy
Show all 9Show fewer
- Small intestine stoma before the operation
- neoadjuvant treatment
- Colon preparation
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Colectomy, CRS+HIPEC
- Medical subject headings
- Colorectal Neoplasms, Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colectomy, CRS+HIPECProcedure or surgery
No special interventions are going to be performed. Fecal samples are going to be taken and analysed
| Study group | Role | What they receive |
|---|---|---|
| Colorectal | 30 patients operated for colorectal cancer Receives: Procedure: Colectomy, CRS+HIPEC | |
| HIPEC | 15 patients operated with CRS+HIPEC for peritoneal carcinomatosis Receives: Procedure: Colectomy, CRS+HIPEC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiome
Change in microbiome in case of insufficiency of the anastomosis
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start31 Jan 2020
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer, Peritoneal Carcinomatosis, Anastomosis InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Tsimogiannis, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252560
- Sponsor's protocol ID
- 2019-04562
- Other IDs
- 2019
- Status last verified
- May 2024
- First submitted
- 31 Jan 2020
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not allowed by the Ethical Committee
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Gut Microbiota in Anastomoses Insufficiency After Resection and Direct Anastomosis for Colorectal Cancer.
- ClinicalTrials.gov ID
- NCT04252560
- Acronym / sponsor ID
- 2019-04562
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colorectal | – | Procedure: Colectomy, CRS+HIPEC30 patients operated for colorectal cancer |
| HIPEC | – | Procedure: Colectomy, CRS+HIPEC15 patients operated with CRS+HIPEC for peritoneal carcinomatosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Ongoing antibiotics treatment
- antibiotics treatment in the last 6 months
- acute surgery
- palliative surgery
- Ulcerös colitis or Crohns disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colectomy, CRS+HIPECNo special interventions are going to be performed. Fecal samples are going to be taken and analysed | Procedure or surgery | Colorectal, HIPEC |
Primary outcome
Microbiome
Time frame: 30 days
Change in microbiome in case of insufficiency of the anastomosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: No. Not allowed by the Ethical Committee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, Peritoneal Carcinomatosis, Anastomosis Insufficiency, run by Uppsala University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.