Gastric CancerNCT05259488
Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy
An observational study of Gastric Cancer and Surgery, 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 gastric cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Surgery, Laparoscopic
- What is being tested?
- immunonutrition
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Jan 2022
- 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
- Adult, Older adult
Study population: All normonourished patients undergoing elective ERAS laparoscopic total gastrectomy for cancer at Minimally Invasive Surgery Unit of Tor Vergata University Hospital
Who may be able to join
- Age >18 years
- Primary gastric cancer
- Preoperative staging I-III
- Eligible for laparoscopic D2 total gastrectomy
Who cannot join
- Acquired or congenital immunodeficiency
- Malnutrition (MNA-SF score < 12)
- Preoperative infection
- Previous gastric surgery
- ASA IV
- Emergency setting
Show all 9Show fewer
- Para-aortic node involvement
- Intraoperative evidence of distant metastasis or peritoneal carcinosis
- Conversion to open surgery
About this study
Official title: Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy: a Single-centre Comparative Study
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 gastric cancer surgery. Potential benefits of combining preoperative IN (PIN) with protocols of enhanced recovery after surgery (ERAS) in reducing LOS in laparoscopic total gastrectomy are yet to be determined.
- Conditions
- Gastric Cancer, Surgery, Laparoscopic, Gastric Neoplasm, Digestive Cancer
- Being tested
- immunonutrition
- Medical subject headings
- Stomach Neoplasms, Gastrointestinal 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 |
|---|---|---|
| patients receiving immunonutrition supply | Dietary Supplement: Immunonutrition nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery Receives: Dietary Supplement: immunonutrition | |
| historical control group | standard dietary advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-days postoperative complications
Rate of any complication after colorectal resection
Measured: up to 30 days after discharge
LOS
number of days between primary colorectal resection and discharge
Measured: up to 30 days after discharge
Secondary outcomes (9)
Anastomotic leak
rate of any postoperative leakage of oesophagojejunal, jejunojejunal anastomosis, clinically, radiologically or endoscopically demonstrated
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 15 days
Measured: up to 30 days after discharge
Readmission
Rate of any unplanned readmission after discharge
Measured: up to 30 days after discharge
Mortality
Rate of any mortality
Measured: up to 30 days after discharge
Time of first defacation
time to first bowel opened to stool
Measured: up to 30 days after discharge
Time of tolerated fluid intake
time to first tolerated fluid intake
Measured: up to 30 days after discharge
Time of tolerated food intake
time to first tolerated food intake
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 posted28 Feb 2022
- Study start1 Jan 2014
- Primary completion31 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric 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
- 51 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
- NCT05259488
- Sponsor's protocol ID
- Protocollo xx/22
- Status last verified
- Feb 2022
- First submitted
- 17 Feb 2022
- Last updated
- 28 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data available on request
Publications
Franceschilli M, Siragusa L, Usai V, Dhimolea S, Pirozzi B, Sibio S, Di Carlo S. Immunonutrition reduces complications rate and length of stay after laparoscopic total gastrectomy: a single unit retrospective study. Discov Oncol. 2022 Jul 11;13(1):62. doi: 10.1007/s12672-022-00490-5.
PubMed 35816241
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Immunonutrition in Laparoscopic Total D2 Gastrectomy: a Single-centre Comparative Study
- ClinicalTrials.gov ID
- NCT05259488
- Acronym / sponsor ID
- Protocollo xx/22
- Conditions
- Gastric Cancer, Surgery, Laparoscopic, Gastric Neoplasm, Digestive Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 28 Feb 2022 (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 gastric cancer surgery. Potential benefits of combining preoperative IN (PIN) with protocols of enhanced recovery after surgery (ERAS) in reducing LOS in laparoscopic total gastrectomy are yet to be determined.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients receiving immunonutrition supply | – | Dietary Supplement: immunonutritionDietary Supplement: Immunonutrition nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery |
| historical control group | – | –standard dietary advice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All normonourished patients undergoing elective ERAS laparoscopic total gastrectomy for cancer at Minimally Invasive Surgery Unit of Tor Vergata University Hospital
Key inclusion criteria (4 listed)
- Age >18 years
- Primary gastric cancer
- Preoperative staging I-III
- Eligible for laparoscopic D2 total gastrectomy
Key exclusion criteria (9 listed)
- Acquired or congenital immunodeficiency
- Malnutrition (MNA-SF score < 12)
- Preoperative infection
- Previous gastric surgery
- ASA IV
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 | patients receiving immunonutrition supply |
Primary outcome
30-days postoperative complications
Time frame: up to 30 days after discharge
Rate of any complication after colorectal resection
LOS
Time frame: up to 30 days after discharge
number of days between primary colorectal resection and discharge
9 secondary outcomes
Anastomotic leak
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
Readmission
Time frame: up to 30 days after discharge
Mortality
Time frame: up to 30 days after discharge
Time of first defacation
Time frame: up to 30 days after discharge
Time of tolerated fluid intake
Time frame: up to 30 days after discharge
Time of tolerated food intake
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 28 Feb 2022.
- Derived from this study: PubMed 35816241Franceschilli M, Siragusa L, Usai V, Dhimolea S, Pirozzi B, Sibio S, Di Carlo S. Immunonutrition reduces complications rate and length of stay after laparoscopic total gastrectomy: a single unit retrospective study. Discov Oncol. 2022 Jul 11;13(1):62. doi: 10.1007/s12672-022-00490-5.
- Individual participant dataSharing planned: No. data available on request
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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 Gastric Cancer and Surgery, 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 4 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 28 Feb 2022. 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?
30-days postoperative complications (time frame: up to 30 days after discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05259488, which also lists 1 linked publication.
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 28 Feb 2022.