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Randomized Trial of Perioperative Probiotics Among Patients Undergoing Major Abdominal Operation
Jan Franko1, Shankar Raman1, Nivedita Krishnan2
1Department of Surgery, Mercy Medical Center, Des Moines, IA.
Insights
Perioperative oral probiotics did not reduce major complications in high-risk gastrointestinal surgery patients. The study found no significant difference in the composite endpoint, but probiotics were linked to higher readmission rates.
Area of Science:
- Gastroenterology
- Surgical Oncology
- Clinical Trials
Background:
- Investigating the utility and safety of short-course oral probiotics in patients undergoing major abdominal operations.
- Perioperative probiotics have shown potential in decreasing length of stay and infectious complications.
- Assessing the impact of perioperative probiotics on major complications in high-risk gastrointestinal surgery patients via a pragmatic randomized trial.
Purpose of the Study:
- To evaluate the efficacy of perioperative oral probiotics (VSL#3) in reducing major complications following high-risk gastrointestinal surgery.
- To determine if probiotic use impacts 30-day mortality, unplanned readmission, or infection rates.
- To assess the safety and specific adverse events associated with perioperative probiotic administration.
Main Methods:
- A double-blind, pragmatic randomized trial involving 135 patients undergoing elective major gastrointestinal operations.
- Patients were randomized to receive either perioperative oral probiotic VSL#3 (n=67) or a placebo (n=68).
- The primary outcome was a 30-day composite endpoint including death, unplanned readmission, or any infection.
Main Results:
- The primary composite endpoint occurred in 25.0% of the placebo group versus 32.8% of the probiotic group (p=0.315).
- No significant difference in 30-day mortality or infection rates was observed between groups.
- The probiotic group had a significantly higher 30-day readmission rate (16.4% vs 4.4%; p=0.022), with several readmissions for dehydration due to diet intolerance or diarrhea.
Conclusions:
- Perioperative use of VSL#3 probiotic did not significantly affect the 30-day composite endpoint of mortality, readmission, or infection.
- A higher readmission rate was observed in patients receiving probiotics, potentially linked to gastrointestinal intolerance.
- Further research is warranted to fully understand the role and safety of perioperative probiotics in major gastrointestinal surgery.
Background:
We investigated the utility and safety of short-course oral probiotics among patients undergoing major abdominal operations. Perioperative probiotics can decrease length of stay and lower rates of infectious complications. We assessed whether perioperative probiotics decrease major complications among patients undergoing high-risk gastrointestinal operations in a pragmatic randomized trial.
Study Design:
This double-blind trial randomized 135 patients undergoing elective major gastrointestinal operations to perioperative oral probiotic VSL#3 taken just before operation and twice daily up to 15 total doses (n = 67) or placebo (n = 68). The primary outcomes measure was 30-day composite end point of death, unplanned readmission, or any infection.
Results:
Primary end point occurred among 17 patients in the placebo group (25.0%) vs 22 patients in the probiotic group (32.8%; p = 0.315). Thirty-day mortality was 2 (2.9%) in the placebo group compared with 1 (1.5%) in the probiotic group (p = 1.000). The placebo group patients experienced lower 30-day readmission rate (3 of 68 [4.4%]) compared with the probiotic group (11 of 67 [16.4%]; p = 0.022). None of the placebo patients were readmitted for dehydration, but 5 of 11 probiotic group patients (45%; p = 0.049) were readmitted for dehydration as a consequence of diet intolerance and/or diarrhea. There was no difference in 30-day infection rate between the groups (15 or 68 [22%] in the placebo group vs 15 of 67 [22.4%] in the probiotic group; p = 0.963).
Conclusions:
Perioperative use of VSL#3 probiotic did not affect 30-day composite end point of mortality, readmission, and infection rate. A significantly higher readmission rate was observed among those exposed to probiotics. Additional studies remain warranted.
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