Some new information from the February 2017 issue of the journal Surgery is just in. A randomized, double blind, placebo-controlled trial from The Netherlands was originally published in 2003 after one year of follow-up. At that time, there was no apparent benefit from an operation to lyse [divide] all adhesions laparoscopically in 52 patients compared to a placebo operation that involved performing only laparoscopy to assess the extent of adhesions in 48.
The current paper looked at outcomes 12 years after the original surgery was done. Follow-up was available for 73% of the patients—42 in the group who had adhesiolysis and 31 who had laparoscopy only.
The authors concluded, “Laparoscopic adhesiolysis was less beneficial than laparoscopy alone in the long term. Secondly, there appeared to be a powerful, long-lasting placebo effect of laparoscopy. Because adhesiolysis is associated with an increased risk of operative complications, avoiding this treatment may result in less morbidity and health care costs.”
Unfortunately the paper has a few flaws.
No cost data were included.
One year after the original surgery, they told the subjects which groups they were in, and those who had only laparoscopy were given the option to undergo adhesiolysis if they wanted to. The math regarding patients in both groups is confusing. Here is the flow diagram for the study:
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In the first paragraph of the results section, it says 12 of the 31 placebo patients underwent adhesiolysis. But the flow chart says "17 placebo patients applied to the offerend adhesiolysis." I do not know what "offerend" means or whether it is simply a typo for “offered.”
The authors said that at the first year of follow-up, quality of life outcomes were no different between the two groups but they did not explain why 12 of the original 48 laparoscopy only patients decided to undergo lysis of adhesions after they were told they were in the placebo group. Requesting another operation implies dissatisfaction with the first procedure.
More math confusion accompanies Table III which is difficult to interpret especially regarding the numbers for the placebo group. The table below indicates that only one patient in the placebo group had a reoperation. But the figure reproduced above shows two patients had lysis of adhesions in the first year after the original surgery. And what about the 12 patients who underwent lysis of adhesions (a reoperation) after they were told they were in the placebo group? If those 12 plus the 2 who had reoperations during the first year of the study were counted as reoperations, there would be no difference in reops between the two groups.
|Click on table to enlarge it|
Much as I’d like to agree with this paper, I can’t.
It doesn’t convince me that lysis of adhesions is worse that a placebo operation, but at least no one in the placebo group required euthanasia because of pain.
An email to the corresponding author of the paper was not answered.