Perioperative Immunonutrition Under Enhanced Recovery After Surgery (PING-ERAS)

University of Putra Malaysia (UPM)

Status: Not yet enrolling

Conditions: Elective Surgery; Gynecological Cancer

Treatments: Dietary Supplement: Immunonutrition oral nutrition supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT06039306

RSCH ID-22-04215-WHE

Details and patient eligibility

About

The goal of this clinical trial is to compare the effect of perioperative immunonutrition supplement in gynecologic cancer patients. The main questions it aims to answer are:

• is there any difference in the nutritional outcomes and functional outcomes between intervention and conventional groups?
• is there any difference in the post-surgical outcomes between intervention and conventional groups?

Participants (intervention) will be provided the immunonutrition supplement before and after operation.

Researchers will compare intervention group with conventional group to see if there is any difference in postoperative outcomes.

Full description

The clinical trial aims to determine the effectiveness of perioperative IMN intervention on postoperative outcomes among GC patients under Enhanced Recovery after Surgery (ERAS) setting. Patients will prescribed with immunonutrition supplement before and after surgery.

Enrollment: 106 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Those who diagnosed with GC
2. Candidates for elective operation treatments

Exclusion criteria

1. Those are involved gastrointestinal tract (complication)
2. Those are diagnosed with GC (metastasis)
3. Allergy to milk/soy/whey protein
4. Participate in other intervention study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

intervention

Experimental group

Description:

Participants will be given 2 servings immunonutrition daily for five (5) days before tentative elective surgery. ERAS protocol will implement and continued 2 servings of immunonutrition for post-operative seven (7) days.

Treatment:

Dietary Supplement: Immunonutrition oral nutrition supplementation

conventional

No Intervention group

Description:

Participants will be on usual diet intake before tentative elective surgery. ERAS protocol will implement and will be prescribed 2 servings of polymeric formula daily only if unable to finish 75% of the diet served in ward.