Colorectal CancerNCT04692545
Preoperative Immunonutrition in Normonourished Patients Undergoing Fast-track Laparoscopic Colorectal Surgery
An observational study of Colorectal Cancer, run by University of Rome Tor Vergata.
Trial summary
Immunonutrition (IN) appears to reduce infective complications and in-hospital length of stay (LOS) after gastrointestinal surgery. More specifically, it seems to be beneficial also in colorectal cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Immunonutrition
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 1 Jun 2020
- 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 normonourished patients undergoing elective ERAS laparoscopic colorectal resections for cancer at Minimally Invasive Surgery Unit of Tor Vergata University Hospital
Who may be able to join
- laparoscopic colorectal resection for cancer following ERAS protocol
- >18 years old
- elective setting
Who cannot join
- age below 18
- malnutrition
- inflammatory bowel disease
- acquired or congenital immunodeficiency
- preoperative infection
- ASA IV
Show all 10Show fewer
- pregnancy
- emergency setting
- conversion to open surgery
- multivisceral resections
About this study
Official title: Preoperative Immunonutrition Versus Standard Dietary Advice in Normo-nourished Patients Undergoing Fast-track Laparoscopic Colorectal Surgery
Immunonutrition (IN) appears to reduce infective complications and in-hospital length of stay (LOS) after gastrointestinal surgery. More specifically, it seems to be beneficial also in colorectal cancer surgery. Potential benefits of combining preoperative IN (PIN) with protocols of enhanced recovery after surgery (ERAS) in reducing LOS in laparoscopic surgery are yet to be determined.
- Conditions
- Colorectal Cancer
- Being tested
- Immunonutrition
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmunonutritionDietary supplement
nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery
| Study group | Role | What they receive |
|---|---|---|
| A | patients receiving immunonutrition supply Receives: Dietary Supplement: Immunonutrition | |
| B | patients receiving standard dietary advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
number of days between primary colorectal resection and discharge
Measured: up to 30 days after discharge
Secondary outcomes (10)
Time to postoperative food intake
number of days between primary colorectal resection and refeeding
Measured: up to 30 days after discharge
Time to first defecation
number of days between primary colorectal resection and first defecation
Measured: up to 30 days after discharge
30-days postoperative complications
Rate of any complication after colorectal resection
Measured: up to 30 days after discharge
Surgical site infection
rate of any surgical site infection clinically demonstrated
Measured: up to 30 days after discharge
Anastomotic leak
rate of any postoperative leakage of colo-rectal, colo-colic or ileo-colic anastomosis, clinically, radiologically or endoscopically demonstrated
Measured: up to 30 days after discharge
Readmission
Rate of any unplanned readmission after discharge
Measured: up to 90 days after discharge
30-days Mortality
Rate of any mortality
Measured: up to 30 days after discharge
Pneumonia
rate of radiologically demonstrated pneumonia
Measured: up to 30 days after discharge
Ileus
rate of any ileus clinically demonstrated
Measured: up to 30 days after discharge
Prolonged length of stay
rate of any patient discharged after 8 days
Measured: up to 30 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Dec 2016
- Primary completion1 Dec 2019
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Sigismondo Sica, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692545
- Sponsor's protocol ID
- REGISTROSPERIMENTAZIONI /21
- Status last verified
- Dec 2020
- First submitted
- 25 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Immunonutrition Versus Standard Dietary Advice in Normo-nourished Patients Undergoing Fast-track Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT04692545
- Acronym / sponsor ID
- REGISTROSPERIMENTAZIONI /21
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 5 Jan 2021 (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.
Immunonutrition (IN) appears to reduce infective complications and in-hospital length of stay (LOS) after gastrointestinal surgery. More specifically, it seems to be beneficial also in colorectal cancer surgery. Potential benefits of combining preoperative IN (PIN) with protocols of enhanced recovery after surgery (ERAS) in reducing LOS in laparoscopic surgery are yet to be determined.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | Dietary Supplement: Immunonutritionpatients receiving immunonutrition supply |
| B | – | –patients receiving standard dietary advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All normonourished patients undergoing elective ERAS laparoscopic colorectal resections for cancer at Minimally Invasive Surgery Unit of Tor Vergata University Hospital
Key inclusion criteria (3 listed)
- laparoscopic colorectal resection for cancer following ERAS protocol
- >18 years old
- elective setting
Key exclusion criteria (10 listed)
- age below 18
- malnutrition
- inflammatory bowel disease
- acquired or congenital immunodeficiency
- preoperative infection
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 |
|---|---|---|
| Immunonutritionnutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery | Dietary supplement | A |
Primary outcome
Length of hospital stay
Time frame: up to 30 days after discharge
number of days between primary colorectal resection and discharge
10 secondary outcomes
Time to postoperative food intake
Time frame: up to 30 days after discharge
Time to first defecation
Time frame: up to 30 days after discharge
30-days postoperative complications
Time frame: up to 30 days after discharge
Surgical site infection
Time frame: up to 30 days after discharge
Anastomotic leak
Time frame: up to 30 days after discharge
Readmission
Time frame: up to 90 days after discharge
30-days Mortality
Time frame: up to 30 days after discharge
Pneumonia
Time frame: up to 30 days after discharge
Ileus
Time frame: up to 30 days after discharge
Prolonged length of stay
Time frame: up to 30 days after discharge
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 5 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by University of Rome Tor Vergata.
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 3 inclusion and 10 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 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Length of hospital stay (time frame: up to 30 days after discharge). 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 5 Jan 2021.