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

NCT06035510 | Completed DMC

• 1 other identifier: 143/2556
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Whey Protein; Postoperative Outcomes; Gynecological Cancer Surgery

Keywords

Whey Protein; Postoperative outcomes; Gynecological Cancer Surgery

Outcome Measures

Primary Outcomes (1)

• Length of post-operative hospital stay

  Length of post-operative hospital stay after operation to discharged

  an average of 3 days after operation

Secondary Outcomes (14)

• operative time

  start to end of operation, an average of 3 hours

• ICU admission

  an average of 3 days after operation

• number of wound infection

  1 and 2 week after operation

• Readmission

  1 month after operation

• Level of serum albumin

  one day before operation and 3 day after operation

Study Arms (2)

whey protein supplement

EXPERIMENTAL

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

Dietary Supplement: whey protein supplement

standard operative care

NO INTERVENTION

Participants followed standard operative care

Interventions

whey protein supplement 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

whey protein supplement

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi

Phaya Thai, ratchathewi, 10400, Thailand

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: September 13, 2023
• Study Start: August 21, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: November 14, 2024

Record last verified: 2023-08

Locations

TH (1)