Rajavithi
Phaya Thai, ratchathewi, 10400, Thailand
NCT Number: NCT06035510
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.
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Notify Me18 year–70 year
Female
Interventional
Not applicable
Phaya Thai, ratchathewi, 10400, Thailand
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: an average of 3 days after operation
Length of post-operative hospital stay after operation to discharged
Time frame: start to end of operation, an average of 3 hours
To compare operative time between intervention group and control group
Time frame: an average of 3 days after operation
Length of ICU admission after operation
Time frame: 1 and 2 week after operation
To compare number of wound infection after operation
Time frame: 1 month after operation
To compare readmission between intervention group and control group
Time frame: one day before operation and 3 day after operation
To compare serum albumin before operation and after operation
Time frame: 3 day and 2 week after operation
To study the side effect of protein supplement
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
Time frame: start to end of operation, an average of 3 hours
To compare intraoperative complication
Time frame: Any events occur within 14 days
To compare postoperative complication between intervention group and control group
Time frame: up to 3 days after operation
To compare postoperative pain score
Time frame: up to 3 days after operation
To compare time of first ambulation after operation
Time frame: up to 3 days after operation
To compare time of first flatus and defecation after operation
Time frame: up to 3 days after operation
To compare Number of additional pain control drug after operation
Time frame: Any events occur within 14 days
To compare post operative fever after operation
Department of Medical Services Ministry of Public Health of Thailand
Other Gov
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