NCT03980704

Brief Summary

Immunomodulating nutrition is supposed to reduce the number of complications and the legnth of the hospital stay during the postoperative period in patients after major gastrointestinal surgery. The aim of the study is to assess the clinical effect of immunomodulating oral nutrition in patients undergoing resection for gastrointestinal cancer in the group of well-nourished patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 10, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

July 26, 2021

Status Verified

July 1, 2021

Enrollment Period

1.8 years

First QC Date

June 5, 2019

Last Update Submit

July 23, 2021

Conditions

General SurgeryCancer of Colon

Keywords

immunonutritionpreoperative nutrition

Outcome Measures

Primary Outcomes (1)

  • Infectious complications

    Number and type of infectious complications

    6 months

Secondary Outcomes (2)

  • Surgical complications

    6 months

  • Length of stay

    14 days

Study Arms (2)

High Protein

ACTIVE COMPARATOR

Provision of 400 ml per day of high protein oral nutritional supplements

Drug: resource protein

Immuno ONS

EXPERIMENTAL

Provision of 400 ml per day of immunostimulating oral nutritional supplements

Drug: IMPACT

Interventions

IMPACTDRUG

Administration of oral immunostimulating oral supplement

Immuno ONS
resource proteinDRUG

Administration of oral high-protein oral supplement

High Protein

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • resectable GI cancer
  • written consent

You may not qualify if:

  • inoperable GI cancer
  • known allergy to the drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanley Dudrick's Memorial Hospital

Skawina, 32-050, Poland

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Stanislaw Klek

    Stanley Dudrick's Memorial Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Unit

Study Record Dates

First Submitted

June 5, 2019

First Posted

June 10, 2019

Study Start

April 1, 2019

Primary Completion

December 31, 2020

Study Completion

March 31, 2021

Last Updated

July 26, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)