Efficacy of polymeric formula on outcomes in robotic pancreatectomy

JRCT ID: jRCTs061230068

Registered date:31/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: The patients who receive robotic pancreatectomy
• Date of first enrollment: 25/12/2023
• Target sample size: 46
• Study type: Interventional
• Intervention(s): Polymeric formula will be provided to patients after robotic pancreatectomy; 3 bottles (600 ml/600 kcal in total) per a day from starting oral intake to discharge. The dosage can be adjusted according to the amount of food eaten.

Outcome(s)

• Primary Outcome: Body weight loss rate before discharge compared to admission

Secondary Outcome

Muscle mass reduction rate before discharge
Body composition changes before discharge
Changes of skeletal muscle mass, weight loss rate, body composition on postoperative 1 month
Nutrition-related blood index (TP, Alb, pre-Alb, T-Chol, lymphocyte count, CRP)
Inflammatory reaction increased (postoperative maximum values of WBC and CRP)
ERAS protocol compliance rate
Postoperative outcomes (length of hospital stay, complications, etc)
Postoperative liver and renal dysfunction (AST, ALT, T-Bil, BUN, Cr)
Postoperative QOL evaluation (PGSAS-45)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Age is 20 years or older
2. The patients who receive robotic pancreatectomy at our institution
3. Patients who have given written informed consent

Exclude criteria

1. severe respiratory dysfunction (arterial PaO2 <70 mmHg)
2. severe cardiac dysfunction (New York Heart Association 3 or more)
3. severe hepatic dysfunction (Child Pugh classification C)
4. severe renal dysfunction (hemodialysis)
5. acute bacterial infections
6. severe psychiatric disorder
7. uncontrolled diabetes
8. milk allergy
9. palliative surgery
10. emergency surgery
11. investigator not available.

Related Information

• Primary Sponsor: Takagi Kosei