Perioperative Immunonutrition for Patients Undergoing CRS and HIPEC

Perioperative Immunonutrition for Patients Undergoing Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03430128

Enrollment

Registered

2018-02-12

Start date

2017-04-23

Completion date

2019-01-22

Last updated

2019-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Metastases

Brief summary

Patients with peritoneal disease commonly present with symptoms of abdominal distension and subacute intestinal obstruction. This results in poor oral intake leading to these patients often presenting in a malnourished state. CRS and HIPEC can potential provide improve survival for these patients, however can be a hazardous procedure, involving multi-organ resections. The risk is especially high in poorly nourished patients. The study investigators hypothesize that perioperative immunonutrition can reduce wound infections and length of hospital stay, and improve perioperative outcomes. To the investigators' knowledge, it has not been evaluated in patients undergoing CRS and HIPEC.

Interventions

DIETARY_SUPPLEMENTIMPACT immunotherapy

Powdered formula that is pre-packaged in individual packets which the patients will be instructed to mix with water before consumption.

DIETARY_SUPPLEMENTENSURE

Liquid milk formula available over the counter

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

The investigators and the clinical team which manages the patient, will be blinded.

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

1. All patients planned for CRS and HIPEC, with sufficient time (5 to 7 days) prior to surgery for start of nutritional supplements are eligible 2. All patients must be able to provide informed consent 3. There are no restrictions to use of contraception

Exclusion criteria

1. Patients who are not able to provide informed consent will be excluded. 2. Patients with a diagnosis of diabetes mellitus will be excluded. 3. Patients not fit for surgery or those who undergo surgery under emergency situations will be excluded. 4. Patients who have intestinal obstruction and not able to consume the nutritional supplements orally will be excluded.

Design outcomes

Primary

Measure	Time frame
Baseline wound infection rates	From date of surgery to date that wound is healed, up to 30 days from surgery

Secondary

Measure	Time frame
Peri-operative complications	Within 30 days from surgery
Length of stay	100 days

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026