Clinical trial NCT06035510: Effect of Whey Protein Supplementation on Postoperative Outcomes After Gynecological Cancer Surgery
Official title: Effect of Whey Protein Supplementation on Postoperative Outcomes After Gynecological Cancer Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Whey Protein
Postoperative Outcomes
Gynecological Cancer Surgery
Keywords: Whey Protein
Postoperative outcomes
Gynecological Cancer Surgery
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2023-09-13
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

1. Intraoperative outcomes, which include the duration of surgery, intraoperative blood loss, and intraoperative complications.
2. 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.
3. The nutritional status outcomes, assessed through serum albumin levels before surgery and on the 3rd day after surgery in both groups of participants.
4. 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.

Eligibility criteria: Inclusion Criteria:

1. A Woman who suspected or diagnosed with ovarian and endometrial Cancer
2. A Woman who candidates for elective Surgical staging of Laparotomy operation in Rajavithi hospital
3. Aged 18-70 years old
4. Can communicate and understand Thai language very well
5. A woman voluntarily participated in the research

Exclusion Criteria:

1. Allergy to whey protein and protein product such as cow milk and egg
2. A Woman who diagnosed with Hypertension, Diabetes Mellitus, Chronic Kidney Disease, Heart disease and Chronic liver disease
3. A Woman who expected difficult operation such as severe pelvic adhesion or required other surgeon for co-evaluation
4. Pregnant woman or breastfeeding
5. A Woman who denied surgery
6. A Woman who currently take a protein supplement
7. A Woman who take Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) , Bisphosphonates, Levodopa ,Tetracycline and Quinolone

Primary outcomes:
measure: Length of post-operative hospital stay
timeFrame: an average of 3 days after operation
Secondary outcomes:
measure: operative time
timeFrame: start to end of operation, an average of 3 hours
measure: ICU admission
timeFrame: an average of 3 days after operation
measure: number of wound infection
timeFrame: 1 and 2 week after operation
measure: Readmission
timeFrame: 1 month after operation
measure: Level of serum albumin
timeFrame: one day before operation and 3 day after operation
measure: Side effect of protein supplement
timeFrame: 3 day and 2 week after operation
measure: Unit of blood transfusion
timeFrame: start to end of operation, an average of 3 hours
measure: Intraoperative complication
timeFrame: start to end of operation, an average of 3 hours
measure: postoperative complication
timeFrame: Any events occur within 14 days
measure: Level of pain score
timeFrame: up to 3 days after operation
measure: time of first ambulation
timeFrame: up to 3 days after operation
measure: time of first flatus and defecation
timeFrame: up to 3 days after operation
measure: Number of additional pain control drug
timeFrame: up to 3 days after operation
measure: Body temperature
timeFrame: Any events occur within 14 days
Other outcomes:
Locations:
city: Phaya Thai
country: Thailand
facility: Rajavithi
state: Ratchathewi
Study officials:
References: