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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Postoperative oral nutritional supplementation after major gastrointestinal surgery: a randomized controlled clinical
Seong-Ho Kong1, Jun Seok Park2, In Kyu Lee3
1Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul, Korea.
Background And Objectives:
This study aimed to evaluate the efficacy of post-operative oral nutrition supplementation after major gastrointestinal surgery.
Methods And Study Design:
A prospective randomized controlled trial was conducted to evaluate 174 subjects who were discharged within 2 weeks after major gastrointestinal surgery. The subjects in the study group were prescribed 400 ml/day of Encover® from the day of discharge for 8 weeks, but no supplementation was allowed in the control group. The primary endpoint was the weight loss rate at 8 weeks after discharge compared with the pre-operative weight, and the secondary endpoints included changes in body weight, body mass index, Patient-Generated Subjective Global Assessment score/grade, hematological/ biochemical parameters, and adverse events evaluated at 2, 4, and 8 weeks after discharge.
Results:
The weight loss rate at 8 weeks after discharge did not differ between two groups (4.23±5.49% vs 4.80±4.84%, p=0.481). The total lymphocyte count, the level of total cholesterol, total protein, and albumin were significantly higher in the study group after discharge. Diarrhea was the most frequent adverse event, and the incidence of adverse events with a severity score of >=3 did not differ between groups (2.3% vs 1.2%).
Conclusions:
The utility of routine oral nutritional support after major gastrointestinal surgery was not proven in terms of weight loss at 8 weeks after discharge. However, it can be beneficial for early recovery of biochemical parameters.
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