Thursday, February 20, 2014

Single-incision vs. standard 4-port laparoscopic cholecystectomy: Part 2

Here's another paper that shows why reading only an abstract can sometimes be misleading.

A prospective trial (abstract here) of 49 patients randomized to single-incision laparoscopic cholecystectomy (SILC) vs. 51 who had standard 4-port laparoscopic cholecystectomy (LC) found that average operative times were 63.5 ± 21.0 minutes for the SILC compared to 43.8 ± 24.2 minutes for those who had LC, and hospital charges were also more than $4000 higher for the SILC patients—both significant differences with p values < 0.0001.

Medical and surgical supplies were the major factors contributing to the increased charges for SILC.

Other than a significantly larger number of females in the SILC group, the patients were similar in baseline characteristics.

Other important considerations such as postoperative pain, hospital length of stay (an average of 24 hours or less for both operations), use of analgesics, cosmetic appearance of the wounds, rates of incisional hernia, and quality of life were similar. Average follow-up was 16 months in both groups. The authors concluded that there was no advantage to SILC.

Since this paper supports my bias against single-incision surgery, I was going to tout it as yet another negative paper like a recent meta-analysis (here) from a group in Croatia showing absolutely no advantage for SILC.

But this sentence from the "Methods" section of the paper foiled my plan. "Before partaking in the study, each surgeon developed his or her SILC technical skills in a laboratory setting and demonstrated proficiency during 5 SILCs under the supervision of a surgeon with experience on more than 50 SILC cases."

This was not mentioned in the abstract.

Are you surprised that a surgeon that might take longer to do SILC, an operation done only 5 times before, than LC, which each of the surgeons had probably done hundreds of times? Although the mean operative duration was longer for SILC, it is a "straw man" in statistical parlance. This may not detract from the rest of the results but certainly has to be considered.

As noted by the authors, the study was underpowered (that is, there weren't enough patients) to detect differences in some of the other outcomes due to difficulty recruiting subjects.

Of 946 patients offered enrollment in the study, only 103 consented. Patients declined to participate either because the surgeon explained that he had done more standard LC procedures, or the patients opted for the SILC because of its supposed cosmetic advantage.

The authors, based at Northwestern University Medical School in Chicago, should be commended for their honesty in explaining their inexperience with SILC to potential subjects of the trial and wonder if other surgeons who perform SILC do this.

This paper also highlights the problems associated with attempts to conduct randomized prospective studies involving new surgical procedures.

Bottom line: The extra costs associated with SILC are not worth it.

Part 1 of this 2-part series on SILC appeared on Tuesday, 2/18.


Anonymous said...

I agree that there is no advantage for SILC, but the 2 disadvanges are probably transient. Operative times and surgeon experience will improve as more and more surgeons do them. Hospital costs should converge for the 2 procedures. At that point, there is no disadvantage in the method.

When that happens (I'd guess in a few years), I think SILC will be used along side 4-port LC mostly depending on surgeon and patient druthers.

Skeptical Scalpel said...

There is one disadvantage to SILC that shows up only in longer follow-up and that is hernias at the incision site.

artiger said...

Scalpel, why are the costs so much more for SILC? Is the multi port just that much more expensive? If it's the longer operating time, then that might be something that diminishes over time as the surgeon gets more proficient with SILC, right?

Skeptical Scalpel said...

I'm not sure, but I think it is the port.

artiger said...

$4000 more for the port? Does it contain a robot or something?

I'm mid career, and plan to practice another 20-25 years. If you were in my position, is SILC something you would try pick up? I'm debating, but the costs don't seem to make it attractive.

Skeptical Scalpel said...

It doesn't make sense to me. Does your rural population worry about the cosmetic results of their cholecystectomies?

artiger said...

For the most part, no, not in the slightest.

I think that answers my question.

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