Peritoneal Metastases Clinical Trial
Official title:
Perioperative Immunonutrition for Patients Undergoing Cytoreductive Surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy
Verified date | September 2019 |
Source | National Cancer Centre, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | January 22, 2019 |
Est. primary completion date | January 22, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Singapore | National Cancer Centre Singapore | Singapore |
Lead Sponsor | Collaborator |
---|---|
National Cancer Centre, Singapore |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Baseline wound infection rates | From date of surgery to date that wound is healed, up to 30 days from surgery | ||
Secondary | Peri-operative complications | Within 30 days from surgery | ||
Secondary | Length of stay | 100 days |
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