- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06035510
Effect of Whey Protein Supplementation on Postoperative Outcomes After Gynecological Cancer Surgery
Major surgeries including gynecological cancer surgery can make surgical stress that leads to increased burden of postoperative complications, delayed length of hospital stay and increased mortality rate. Protein is one of the essential factors that contribute to the recovery of patients following surgery, as the surgical process increases protein breakdown in the body. Providing patients with an adequate amount of protein helps enhance muscle building, aids in muscle repair, and reduces postoperative inflammation.
One study administered a fluid containing a combination of whey protein and carbohydrates to cancer patients in preoperative and postoperative periods. The result of the study shows that intervention group can reduce the length of hospital stay and postoperative complications.
However, studies focusing on the use of only-protein supplement to improve surgical complications in gynecological cancer patients are limited. This study aims to investigate the administration of protein supplement before and after surgery in gynecological cancer patients its contribution to the reduction of length of hospital stay and postoperative complications at Rajavithi Hospital.
Study Overview
Status
Intervention / Treatment
Detailed Description
During admission, Participants will be randomized by a computer program into two groups as the whey protein supplement group and control group. Both groups will undergo nutritional assessment on the first day of admission before surgery by the Rajavithi Subjective Global Assessment tool and serum albumin level.
The whey protein supplement group : participants will receive isolated whey protein in the form of two packets of isolated whey protein powder (each packet containing 11.5 grams, totaling to 23 grams) mixed with water in a 350 milliliter drinking bottle at 6.00 p.m. on first day before operation. After the operation, participants will receive the same form of protein supplement as before surgery at 6.00 a.m. on the first day after operation.
The control group : participants will receive standard care, which includes fasting from food after midnight on the night before surgery and other standard surgical protocols.
After surgery, participants will be assessed based on
- Intraoperative outcomes, which include the duration of surgery, intraoperative blood loss, and intraoperative complications.
- The postoperative outcomes, which include length of hospital stay, duration of stay in the intensive care unit (ICU), postoperative complications, postoperative pain, time to first ambulation , time to first flatus , nausea and vomiting symptoms, increased requests for pain medication, fever more than 24 hours after surgery , wound infection and readmission.
- The nutritional status outcomes, assessed through serum albumin levels before surgery and on the 3rd day after surgery in both groups of participants.
- The side effects of whey protein supplement, in the experimental group participants, which will evaluate include allergic reactions, nausea, vomiting, abdominal discomfort, bloating, headache, reduced appetite, elevated creatinine levels, and increased liver function levels on the 3rd day and two weeks after surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Wiranchana Chitti, M.D.
- Phone Number: 60115 022062900
- Email: wiranchanaparn@gmail.com
Study Contact Backup
- Name: Putsarat Insin, M.D.
- Phone Number: 60115 022062900
- Email: mamieo3020@gmail.com
Study Locations
-
-
Ratchathewi
-
Phaya Thai, Ratchathewi, Thailand, 10400
- Recruiting
- Rajavithi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A Woman who suspected or diagnosed with ovarian and endometrial Cancer
- A Woman who candidates for elective Surgical staging of Laparotomy operation in Rajavithi hospital
- Aged 18-70 years old
- Can communicate and understand Thai language very well
- A woman voluntarily participated in the research
Exclusion Criteria:
- Allergy to whey protein and protein product such as cow milk and egg
- A Woman who diagnosed with Hypertension, Diabetes Mellitus, Chronic Kidney Disease, Heart disease and Chronic liver disease
- A Woman who expected difficult operation such as severe pelvic adhesion or required other surgeon for co-evaluation
- Pregnant woman or breastfeeding
- A Woman who denied surgery
- A Woman who currently take a protein supplement
- A Woman who take Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) , Bisphosphonates, Levodopa ,Tetracycline and Quinolone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: whey protein supplement
Participants are given lactose-free Isolated whey protein 23 gm (containing with whey protein isolate 98.7 % ,Soya lecithin 1.3 % ) which mixed with water 350 ml at 6 p.m prior to surgery and 6.00 a.m. at first day after post surgery
|
Participants are given Isolated whey protein supplement in evening before surgery and first day of post operation to compare with standard operative care on postoperative outcomes after gynecological cancer surgery
|
No Intervention: standard operative care
Participants followed standard operative care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of post-operative hospital stay
Time Frame: an average of 3 days after operation
|
Length of post-operative hospital stay after operation to discharged
|
an average of 3 days after operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
operative time
Time Frame: start to end of operation, an average of 3 hours
|
To compare operative time between intervention group and control group
|
start to end of operation, an average of 3 hours
|
ICU admission
Time Frame: an average of 3 days after operation
|
Length of ICU admission after operation
|
an average of 3 days after operation
|
number of wound infection
Time Frame: 1 and 2 week after operation
|
To compare number of wound infection after operation
|
1 and 2 week after operation
|
Readmission
Time Frame: 1 month after operation
|
To compare readmission between intervention group and control group
|
1 month after operation
|
Level of serum albumin
Time Frame: one day before operation and 3 day after operation
|
To compare serum albumin before operation and after operation
|
one day before operation and 3 day after operation
|
Side effect of protein supplement
Time Frame: 3 day and 2 week after operation
|
To study the side effect of protein supplement
|
3 day and 2 week after operation
|
Unit of blood transfusion
Time Frame: start to end of operation, an average of 3 hours
|
To compare unit of blood transfusion during operation between intervention group and control group
|
start to end of operation, an average of 3 hours
|
Intraoperative complication
Time Frame: start to end of operation, an average of 3 hours
|
To compare intraoperative complication
|
start to end of operation, an average of 3 hours
|
postoperative complication
Time Frame: Any events occur within 14 days
|
To compare postoperative complication between intervention group and control group
|
Any events occur within 14 days
|
Level of pain score
Time Frame: up to 3 days after operation
|
To compare postoperative pain score
|
up to 3 days after operation
|
time of first ambulation
Time Frame: up to 3 days after operation
|
To compare time of first ambulation after operation
|
up to 3 days after operation
|
time of first flatus and defecation
Time Frame: up to 3 days after operation
|
To compare time of first flatus and defecation after operation
|
up to 3 days after operation
|
Number of additional pain control drug
Time Frame: up to 3 days after operation
|
To compare Number of additional pain control drug after operation
|
up to 3 days after operation
|
Body temperature
Time Frame: Any events occur within 14 days
|
To compare post operative fever after operation
|
Any events occur within 14 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 143/2556
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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