Effect of Whey Protein Supplementation on Postoperative Outcomes After Gynecological Cancer Surgery

NCT ID: NCT06035510

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-21
• Study Completion Date: 2024-10-31

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.

Conditions

Whey Protein; Postoperative Outcomes; Gynecological Cancer Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

whey protein supplement

Intervention Type: DIETARY_SUPPLEMENT

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

standard operative care

Participants followed standard operative care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

whey protein supplement

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Medical Services Ministry of Public Health of Thailand

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rajavithi

Phaya Thai, ratchathewi, Thailand

Countries

Thailand

Other Identifiers

143/2556

Identifier Type: -

Identifier Source: org_study_id