Questionable studies

Lancet

04/10/2003 
by Harvey McConnell

The increasingly popular laparoscopic adhesiolysis cannot be recommended as treatment for adhesions among patients with chronic abdominal pain. 

This call is made by Dutch clinicians following a multi-centre randomised trial who found, after one year, that there was no statistical difference in pain relief between women who had laparoscopic adhesiolysis or those who had no treatment at all. 

Laparoscopic adhesiolysis, which treats severe abdominal pain by the removal of adhesions–is both controversial and not evidence based adds the report by Dr Dingeman Swank and colleagues from Groene Hart Hospital, the Netherlands. Their original hypothesis was that laparoscopic adhesiolysis leads to substantial pain relief and improvement in quality of life in patients with adhesions and chronic abdominal pain. 

Chronic abdominal pain is a diagnostic and treatment challenge, the clinicians point out, and among many women the cause is not identified. Laparoscopy can exclude other causes of pain among 35 to 56% of patients, leading to the supposition that adhesions are the only explanation. 

Treatment was concealed from patients. Pain was assessed for one year by visual analogue score (VAS) score (scale 0 to 100), pain change score, use of analgesics, and quality of life score. 

After diagnostic laparoscopy to confirm adhesions, patients were randomly allocated laparoscopic adhesiolysis (52) to remove adhesions, or no intervention (48). Both groups reported substantial pain relief and a significantly improved quality of life, but there was no difference between the groups (mean change from baseline of VAS score at 12 months: difference 3 points). 

The clinicians found that in both groups, the maximum pain relief was obtained at three months but had waned at six months. 

Dr Swank and colleagues conclude that diagnostic laparoscopy is a safe procedure and reveals curable disorders in patients with chronic abdominal pain. "However, laparoscopic adhesiolysis is associated with morbidity and provides no more relief of chronic pain than diagnostic laparoscopy alone. Its value lies not in the adhesiolysis but in the diagnostic aspect of the procedure." 

Lancet 2003;361:1247-51.

This are Dr. Kruschinski’s comments to the conclusions of this study:

"However, laparoscopic adhesiolysis is associated with morbidity and provides no more relief of chronic pain than diagnostic laparoscopy alone. Its value lies not in the adhesiolysis but in the diagnostic aspect of the procedure." 

The study says only something about the "magic" effect of surgical tools at all. Pain has multiple factors and if you apply one tool like a surgery, therapeutic or diagnostic, it does work, as patients are influenced by the procedure itself and they think the adhesiolysis was effective. If the patients however have evident adhesions, they will get in pain one day, maybe after some more time or they will end up with a bowel obstruction. 

In my opinion this study is unethical as it's for sure that this procedure with or without removal of adhesions causes harm to the patients (unnecessary surgical intervention and morbidity) !!! and says anything… 

Additionally as they are speaking about carbon dioxide laparoscopy without any sufficient adhesion barrier, it might be that most of the patients got their adhesions back and therefore 
both groups had got the same adhesion score as before surgery, one group with adhesions and with adhesiolysis (which might come back after inadequate surgery) and the other group with 
adhesions without adhesiolysis, so maybe the conclusions of this study could be, that the adhesiolysis didn't work at all and thus both groups have similar initial pain relief which will be for sure followed with adhesions complication if the patients have adhesions. 

To obtain results if a successful adhesiolysis provides pain relief, would be extremely important. Fo such a study one would need a well designed study protocoll with an adhesiolysis and a second look laparoscopy to be able to describe if the adhesiolysis was successfull or not. Thus they would be able to conclude if a successful adhesiolysis gives adequate results in pain relief and other symptoms of adhesions like re-surgery for adhesions or bowel obstruction. 

I think for ARD sufferers there should be only one conclusion from this publication: 
" It's better not to have any surgery than a surgery that doesn't work !" 
But of course a surgery with a surgeon who can provide a successful adhesiolysis is always better than to wait in pain till the next bowel obstruction with emergency laparotomy … 

Daniel Kruschinski, MD