The POSCH design and patient selection criteria, baseline characteristics, and clinical results have been published.
Baseline determinations were made within 6 months before randomization into POSCH.
Initially, two of the four POSCH centers determined serum creatinine levels in their local hospital laboratories.
Each death has been assigned a specific cause by the POSCH Mortality Review Committee.
The randomized controlled clinical trial data from POSCH clearly demonstrate that PIB, as a single intervention modality, is as effective as, or even more effective than, double- or triple-drug regimens.
In the POSCH study, 94% of patients undergoing the operation had not had a reversal after an average of 9.
The only other death attributable to PIB in POSCH patients was from intra-abdominal sepsis after several of the operation.
At each POSCH follow-up visit, the surgery group patients reported an average of more than three bowel movements per day; however, this increase in stool frequency was well tolerated by nearly all of the patients.