Does decompression of the median ligament during keyhole surgery help patients with long-term abdominal complaints? This question forms the main focus of a national study induced by MST and UT. The National Health Care Institute of the Netherlands has granted €1.3 million in funding for this project. The National Health Care Institute of the Netherlands and ZonMw have granted € 1.3 million for this purpose through the Subsidy Scheme for Promising Care.
Long-term abdominal complaints are widespread and have a major negative impact on people’s quality of life. One of the possible causes of abdominal complaints is. Median Arcuate Ligament Syndrome (MALS) This condition is characterised by the compression of the celiac artery by a band of diaphragm known as the median arcuate ligament during respiration. A national study led by Medisch Spectrum Twente (MST) and the University of Twente (UT) is examining the effect of releasing the median ligament in patients with long-term abdominal complaints associated with MALS. This study is being led by vascular surgeon Bob Geelkerken, a vascular surgeon at MST and a professor at UT’s Techmed Centre.
The CARoSO study
In the Netherlands, approximately 500 patients, often young people, suffer from symptoms consistent with MALS each year. Many are referred to MST, the Netherlands’ expert centre for gastrointestinal ischaemic disorders, in order to receive an expert assessment and possibly undergo keyhole surgery to release the median ligament. Between 70% and 80% of patients experience a durable improvement in their quality of life after undergoing this form of surgery developed at MST. However, it has never been conclusively proven whether the positive results experienced by patients are due to the median ligament being released or a placebo effect. The latter is the effect produced by the patient’s own expectation of the treatment, rather than the actual decompression of the median ligament.
The national study will examine whether releasing the median ligament provides a long-term reduction in symptoms or whether the placebo effect is at work. Seventy patients are participating in the study. In 35 patients, the median ligament will be released during keyhole surgery. The other 35 patients will undergo a ‘faux’ operation in which they are put under anaesthesia and small incisions like those during keyhole surgery are made in the abdomen, but without decompressing the median ligament. The physicians of the patient and the patients themselves are unaware of the type of operation carried out in each case. Thanks to the subsidy of € 1.3 million from The National Health Care Institute and ZonMw, the costs of the promising care to the patients whose diaphragm band is cut can be reimbursed. Because it concerns care that is not yet reimbursed through basic insurance, such costs are often difficult to finance.
If the study demonstrates that keyhole surgery is effective, the 35 patients who underwent the faux surgery will be given the opportunity to have the real operation. The granting of the subsidy contributes to the fact that if the effectiveness of the intervention is deemed proven, the care is quickly admitted to the basic package. The subsidy scheme stipulates that the Health Care Institute immediately starts an assessment at the end of the research process. This must be completed within 6 months.
Bob Geelkerken explains: ‘This is a national study supported by all colleagues in my field of expertise. Personally, I am convinced that laparoscopic release of the median ligament is beneficial. This is evident from the conversations I have with my patients and from the results after the keyhole surgery that we did as preliminary work.
However, this claim has never been scientifically proven. That is what we now hope to achieve in this national study. Whatever the outcome, this unique four-year study will be worthwhile.’
Evidence for inclusion in basic health insurance plan
During the study, the social costs of Celiac Artery Compression Syndrome are being assessed by UT’s Department of Health Technology and Services Research (HTSR). CARoSO is receiving support from the Healthcare Institute within the framework of the promising care programme Zorginstituutnederland.nl/werkagenda/multipromising-care and the Dutch Mesenteric Ischemia Study Group (dmisg.nl).
